[Senate Hearing 105-516]
[From the U.S. Government Publishing Office]
S. Hrg. 105-516
Part I
THE SAFETY OF FOOD IMPORTS
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HEARING
before the
PERMANENT
SUBCOMMITTEE ON INVESTIGATIONS
of the
COMMITTEE ON
GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
ONE HUNDRED FIFTH CONGRESS
SECOND SESSION
__________
PART I
__________
MAY 14, 1998
Printed for the use of the Committee on Governmental Affairs
-----------
U.S. GOVERNMENT PRINTING OFFICE
49-134 CC WASHINGTON : 1998
_______________________________________________________________________
For sale by the Superintendent of Documents, Congressional Sales Office
U.S. Government Printing Office, Washington, DC 20402
COMMITTEE ON GOVERNMENTAL AFFAIRS
FRED THOMPSON, Tennessee, Chairman
WILLIAM V. ROTH, Jr., Deleware JOHN GLENN, Ohio
TED STEVENS, Alaska CARL LEVIN, Michigan
SUSAN M. COLLINS, Maine JOSEPH I. LIEBERMAN, Connecticut
SAM BROWNBACK, Kansas DANIEL K. AKAKA, Hawaii
PETE V. DOMENICI, New Mexico RICHARD J. DURBIN, Illinois
THAD COCHRAN, Mississippi ROBERT G. TORRICELLI,
DON NICKLES, Oklahoma New Jersey
ARLEN SPECTER, Pennsylvania MAX CLELAND, Georgia
Hannah S. Sistare, Staff Director and Counsel
Leonard Weiss, Minority Staff Director
Lynn L. Baker, Chief Clerk
------
PERMANENT SUBCOMMITTEE ON INVESTIGATIONS
SUSAN M. COLLINS, Maine, Chairman
WILLIAM V. ROTH, Jr., Deleware JOHN GLENN, Ohio
TED STEVENS, Alaska CARL LEVIN, Michigan
SAM BROWNBACK, Kansas JOSEPH I. LIEBERMAN, Connecticut
PETE V. DOMENICI, New Mexico DANIEL K. AKAKA, Hawaii
THAD COCHRAN, Mississippi RICHARD J. DURBIN, Illinois
DON NICKLES, Oklahoma ROBERT G. TORRICELLI, New Jersey
ARLEN SPECTER, Pennsylvania MAX CLELAND, Georgia
Timothy J. Shea, Chief Counsel and Staff Director
David McKean, Minority Staff Director
Pamela Marple, Minority Chief Counsel
Mary D. Robertson, Chief Clerk
C O N T E N T S
------
Opening statements:
Page
Senator Collins.............................................. 1
Senator Glenn................................................ 3
Senator Durbin............................................... 5
Senator Levin................................................ 7
Senator Akaka................................................ 21
Senator Cochran.............................................. 35
Senator Brownback............................................ 36
WITNESSES
Thursday, May 14, 1998
Mary Ellen Camire, Associate Professor and Chair, Department of
Food Science and Human Nutrition, University of Maine.......... 9
Robert E. Robertson, Associate Director, Food and Agriculture
Issues, U.S. General Accounting Office; accompanied by Keith
Oleson, San Francisco Regional Office, U.S. General Accounting
Office......................................................... 23
Reggie Jang, Former Food and Drug Administration Consumer Safety
Inspector...................................................... 41
Alphabetical List of Witnesses
Camire, Mary Ellen:
Testimony.................................................... 9
Prepared Statement........................................... 47
Jang, Reggi:
Testimony.................................................... 41
Robertson, Robert E.:
Testimony.................................................... 23
Prepared Statement........................................... 54
APPENDIX
Exhibit List for May 14, 1998 Hearing
1. Chart prepared by the Permanent Subcommittee on
Investigations, ``U.S. Import of Fruit and Vegetables''........ 64
2. List of Imported Fruit and Vegetables on display at May 14,
1998 Permanent Subcommittee on Investigations' hearing......... 65
3. GAO Report to the Chairman, Permanent Subcommittee on
Investigations, Committee on Governmental Affairs, U.S. Senate,
FOOD SAFETY: Federal Efforts to Ensure the Safety of Imported
Foods Are Inconsistent and Unreliable, April 1998, GAO/RCED-98-
103............................................................ 66
4. Charts prepared by the General Accounting Office:
a. GActions Taken on Imported Food Entries, FDA, FY 1997..... 129
b. GActions Taken on Imported Food Entries Regulated by FSIS,
CY 1997.................................................... 130
5. Statement for the Record, American Frozen Food Institute.... 131
6. Statement for the Record, American Meat Institute........... 183
7. Statement for the Record, Food Marketing Institute.......... 186
8. Statement for the Record, Grocery Manufacturers of America.. 188
9. Statement for the Record, National Broiler Council.......... 205
10. Statement for the Record, National Consumers League......... 207
11. Statement for the Record, National Fisheries Institute...... 213
12. Statement for the Record, National Food Processors
Association.................................................... 215
13. Statement for the Record, National Restaurant Association... 219
14. Statement for the Record, Western Growers Association....... 222
15. Statement for the Record, Wild Blueberry Commission of Maine 227
16. Statement for the Record, Food Industry Trade Coalition..... 229
17. Statement for the Record, Deputy Secretary of Agriculture,
Government of Mexico......................................... 232
18. Statement for the Record, Fresh Produce Association of the
Americas....................................................... 234
19. CRS Report to Congress, ``Food Safety: Recommendations for
Changes in the Organization of Federal Food Safety
Responsibilities, 1949-1997,'' April 21, 1998, by Donna U.
Vogt, Analyst in Social Sciences, Science, Technology, and
Medicine Division, Congresisonal Research Service, Library of
Congress....................................................... 238
THE SAFETY OF FOOD IMPORTS
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THURSDAY, MAY 14, 1998
U.S. Senate,
Permanent Subcommittee on Investigations,
of the Committee on Governmental Affairs,
Washington, DC.
The Subcommittee met, pursuant to notice, at 9:33 a.m., in
room SD-342, Dirksen Senate Office Building, Hon. Susan
Collins, Chairman of the Subcommittee, presiding.
Present: Senators Collins, Brownback, Domenici, Cochran,
Glenn, Levin, Akaka, and Durbin.
Staff Present: Timothy J. Shea, Chief Counsel/Staff
Director; Mary D. Robertson, Chief Clerk; Stephanie Smith,
Investigator (Congressional Fellow); Don Mullinax, Chief
Investigator; Kirk E. Walder, Investigator; Lindsey E. Ledwin,
Staff Assistant; Pamela Marple, Minority Chief Counsel; Beth
Stein, Counsel to the Minority; Brian Benczkowski (Senator
Domenici), Butch Burke (Senator Stevens), Michael Loesch
(Senator Cochran), Steve Abbott (Senator Collins); Felicia
Knight (Senator Collins); Kevin Mattis (Senator Specter);
Carolyn Farris (Senator Brownback); Linda Gustitus (Senator
Levin); Nanci Langley (Senator Akaka); Marianne Upton (Senator
Durbin); Antigone Popamianos (Senator Levin); Scott Brady
(Senator Cleland); Pat Souders (Senator Durbin); Melissa Merz
(Senator Durbin); Nick Castro (Senator Durbin); and Kevin Mulry
(Senator Durbin).
OPENING STATEMENT OF SENATOR COLLINS
Senator Collins. Good morning. The Subcommittee will please
come to order. Today, the Permanent Subcommittee on
Investigations holds its first in a series of hearings on the
safety of imported food. This hearing is part of an effort
launched last June by the Subcommittee to ensure that our food
supply remains one of the safest in the world.
Food safety is a serious and growing public health problem
in America. The General Accounting Office has reported that as
many as 81 million cases of foodborne illnesses and more than
9,000 related deaths occur in the United States each year. The
medical treatment and lost productivity resulting from
foodborne illnesses cost us billions of dollars each year.
The safety of our Nation's food supply is something that we
take for granted. Whether we shop at a corner convenience store
or a deluxe modern supermarket, we expect the quality of our
food products to be consistently high. We fill our grocery
carts, assuming that the food we bring home to our families is
tasty, wholesome, and, most of all, safe. We have come to
expect year-round availability of the fruit and vegetables that
we used to enjoy only in the summer months.
Today, we live in a global economy where national borders
are more open and where trade barriers have fallen. Free trade
has helped fuel our economic expansion. However, with free and
open trade comes the responsibility to protect that part of the
food supply imported into our country.
Much of our food safety efforts in the past have focused on
American products. Ensuring food safety, however, can no longer
be achieved by focusing solely on domestic production and
distribution. Foods can be contaminated at any point throughout
the food chain, from the farm to the table. But in the case of
imported foods, we must be especially vigilant because part of
that chain exists outside the United States.
Recent reports have raised serious questions about the
safety of some imported fruit and vegetables. In 1997, for
example, over 200 students and teachers in Michigan developed
hepatitis after eating frozen strawberries imported from
Mexico. The imported strawberries also caused at least 29 cases
of hepatitis in my home State of Maine.
Moreover, in 1996 and 1997, over 2,000 people were infected
with Cyclospora after eating tainted raspberries imported from
Guatemala. This was one of the largest outbreaks of foodborne
disease in recent years. Once again, this outbreak reached the
State of Maine.
In response to these and other disturbing outbreaks, last
summer, the Subcommittee undertook an extensive investigation
of the systems and procedures used by Federal agencies to
ensure that the imported food that reaches American consumers
is safe. To assist the Subcommittee in its ongoing
investigation, I requested the General Accounting Office to
examine the efforts of Federal agencies to ensure the safety of
food imports. During our hearing today, the Subcommittee will
hear the findings from that GAO review, which represent a
serious indictment of the standard practices used by the
Federal Food and Drug Administration.
The Subcommittee's hearing will focus on the following
important questions. First, how does the increasing volume of
imported foods affect the safety of the U.S. food supply?
Second, are resources efficiently deployed by the agencies
charged with ensuring the safety of food imports? Third, are
the agencies charged with protecting our food supply
effectively conducting inspections at ports of entry? And
fourth, are sufficient controls in place to prevent unsafe
foods that are detected at our borders from entering U.S.
commerce?
Our markets are increasingly filled with imported fruit and
vegetables. Shipments of imported foods have more than doubled
during the past 5 years. In 1996, the United States imported
$7.2 billion worth of fruit and vegetables from at least 90
different countries, an increase in dollar terms of 48 percent
from 1990.
In January of this year, a typical American grocery store
displayed for sale fruit and vegetables not only from the
United States, but also from 28 other countries, and this trend
will continue. The Federal Food and Drug Administration has
projected that imports of fruit and vegetables will go up by
another 33 percent between now and the year 2002. Yet, despite
the increasing volume, the FDA inspections of imported fruit
and vegetables have declined sharply. Those two trends are
shown on the chart that is displayed.\1\
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\1\ See Exhibit No. 1 that appears in the Appendix on page 64.
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The National Cancer Institute is encouraging us to eat at
least five servings a day of fruit and vegetables. As Federal
officials encourage Americans to follow this excellent advice,
the FDA and other Federal agencies responsible for food safety
need to ensure that consumers can, indeed, have confidence in
the safety of the food we eat. As more pathogenic organisms are
showing up on fresh produce and as consumers become more aware
of the serious consequences of foodborne illnesses, consumers
are looking to the government to better protect our food
supply.
The safety of food imports is literally a life and death
issue for many Americans. The most vulnerable are the very
young, the very old, and the very ill. As the vast majority of
our food supply is safe, consumers obviously should not stop
eating fruit and vegetables. However, the import inspection
system must be improved so that consumers are protected from
the risk of unsafe foods, particularly when contamination often
is not detectable to the average consumer.
Finally, let me emphasize that this hearing is the
Subcommittee's first step in shedding light on the weaknesses
in the Nation's food import system. We will be holding three
other hearings later this year. I want to make sure that our
current programs are being effectively managed and that
resources are focused on those imports posing the greatest
risk. American consumers deserve no less than the safest
possible food supply.
We will hear this morning from three witnesses. Dr. Mary
Ellen Camire, Chair of the Department of Food Science and Human
Nutrition of the University of Maine will discuss the
seriousness of foodborne pathogens associated with imported
foods.
We will then hear testimony from Robert Robertson, the
Associate Director for Food and Agriculture Issues for the
General Accounting Office. He will testify about the weaknesses
in the current food import system discovered during GAO's
recent examination.
Reggie Jang, a former FDA consumer safety inspector, will
be our third witness this morning. He is awaiting sentencing on
Federal bribery charges related to his FDA job. With almost 36
years of experience as an FDA inspector, Mr. Jang will discuss
his first-hand knowledge of inspecting food imports.
We look forward to hearing from these witnesses this
morning and to exploring ways to improve the food import
system.
It is now my pleasure to recognize the Ranking Minority
Member of the Subcommittee, the distinguished senior Senator
from Ohio, John Glenn, for any statement that he may have.
OPENING STATEMENT OF SENATOR GLENN
Senator Glenn. Thank you, Madam Chairman, very much. I do
welcome this hearing this morning. I want to thank you for your
role in setting up this hearing to investigate this very
important matter of food safety.
In the past 10 years, as you said, Americans have become
much more healthy eaters. It all started off with our spouses
giving us vitamins at the breakfast table and we hear over the
radio, fruit, vegetables, grains, and beans, that is what you
want to eat. You want to stay away from fat. That is bad. Do
not plug up your arteries, and all this stuff. We are much more
health conscious now than we were just a few years ago. There
probably is not a person in this room that does not know what
their approximate cholesterol count is. We are very much more
tuned into health matters.
We now want to be healthy eaters, and so we are consuming
more fresh fruit and vegetables than ever before.
Unfortunately, the farmers in this country are not keeping up
with all that. We get so much of our produce from California,
Florida, and other States, but we cannot grow enough fresh
fruit and vegetables to really keep up with all of our demand
completely, especially during the winter months. So, as a
result, we are importing more fresh foods from other countries
than ever before.
We do insist that imported meat and poultry adhere to rigid
U.S. safety standards, but there are no equivalent standards
for other imported foods. In other words, we do not really know
whether vegetables and fruit from other countries have been
grown, harvested and packed in safe and sanitary conditions.
I am increasingly concerned with the speed with which new
diseases are developing and showing up in our food supply. In
my home State of Ohio, several hundred people have reportedly
been seriously ill for weeks as a result of eating fruit
contaminated with the parasite Cyclospora, and I think we will
hear more about that later this morning.
Two years ago, I had never heard of Cyclospora. I did not
know there was such a thing. I do not know how new it is or
whether it has been around or whether it just immigrated into
this country, but I had never even heard of Cyclospora, and
yet, here it is and several hundred people are sick with it.
There has never been an outbreak in the United States, as I
understand it.
I want to emphasize that we do not want to scare people to
death. The majority of our food in this country is safe and
government agencies charged with overseeing food inspection
work hard to keep it safe. But are we doing enough and are the
standards enough, or what the inspectors have to work with in
the ways of laws that really protect our people, are they
adequate? That is what we have to address, also.
I want to thank our Chairwoman for bringing this issue to
the forefront. I hope we can enact legislation to ensure that
all food, not just most of it, but all food eaten by American
consumers, whether imported or domestic, has to come up and
meet the same rigorous standards. There cannot be dual
standards, one that is less for imported food and higher for
what we have in this country.
I look forward to hearing from the witnesses today about
ways we can work to ensure the safety of our food. Thank you
very much.
Senator Collins. Thank you, Senator Glenn.
Senator Durbin has also been a leader in this issue and I
would call upon him now for any opening statement that he might
have.
OPENING STATEMENT OF SENATOR DURBIN
Senator Durbin. Thanks, Senator Collins, and thank you for
having this hearing. Food safety is an issue that I got
interested in about 10 years ago when I was serving in the
House of Representatives on the Agriculture Appropriations
Subcommittee, which was responsible for the USDA and the Food
and Drug Administration.
I think one of the most educational trips that I have ever
taken as a member of Congress was when I spent a day in
Nogales, Arizona, at the border and watched the actual
inspection process. I watched a sample being taken by an FDA
employee and then I followed that sample into the Los Angeles
laboratory. It arrived the next day. I learned more about the
process of how it works by just being there firsthand than I
could have ever possibly learned in the course of a hearing.
There were some real eye-openers 10 years ago, and I am
anxious to find out from the FDA how many of them have changed.
The man who took the sample in Nogales, Arizona, was a retired
individual who came to work on a bicycle. This was a part-time
job. He knew everybody, including the truckers as they came
through, and he took the sample. He put it, as he was supposed
to, appropriately, in the brown paper bags and then took it off
to be shipped by bus to Los Angeles. Congress had cut the money
for shipments of the samples by airplane. We decided we could
not afford that any longer.
Well, the problem, of course, is obvious. By the time the
sample reached Los Angeles, the food had already reached the
market somewhere, and if there was something wrong with it, the
best the FDA could do was hope that they would catch it the
next time around. That is the system that was in place then and
I am anxious to find out if it has changed much.
Incidentally, that FDA laboratory in Los Angeles was a
mess. The ceilings were falling down. There was inadequate
equipment. I left there really concerned about it. I think
there have been substantial improvements since then in new
headquarters and in new equipment, which are certainly long
overdue. The condition of labs, I think, is part of this, as
well.
There is no doubt that there has been a dramatic increase
in the import of fruit and vegetables in this country. Walk
into any produce section of any grocery store in America and
look at what you see and compare that to what you might have
seen 20 years ago. Our appetites are so diverse now. We want to
try everything, and the produce department tries to offer
everything. We do not grow everything in America, so they bring
it in from countries all around the world.
But the interesting thing is, as the imports of fruit and
vegetables have increased dramatically, creating a lot of
health challenges, we have not met our obligation on Capitol
Hill to provide the Food and Drug Administration with the
resources to keep up with this flood of imports of fruit and
vegetables. I think that this hearing is going to pinpoint that
and really show that not only does the FDA have the
responsibility to inspect, but Congress has a responsibility to
provide the resources so that FDA can inspect.
As I look at some of the statistics that we have here
before us, it is troubling to see all of this outbreak of
illness that is related to fruit and vegetables. I know that
there are other food products that are equally dangerous. I
want to emphasize, as the Chairman has, that we are blessed
with the safest food supply in the world, but we can do a lot
better. Let me suggest a couple of areas where we can do
better.
First, this recent GAO report recommends the formation of a
single food inspection agency for the United States of America.
This radical idea was proposed in 1994 by Vice President Gore,
and I have introduced legislation, the Safe Food Act, S. 1465,
to replace the fragmented Federal food safety system with a
single, consolidated, independent agency with responsibility
for all Federal food inspection.
Currently, there are 12 different Federal agencies and 35
different laws governing food safety and inspection functions.
With so many bureaucrats in the kitchen, it is no wonder that
breakdowns occur. Overlapping jurisdiction, Federal agencies
without accountability, and resources that are wasted are just
inexcusable. A single independent agency that will focus our
policy and improve the enforcement of food safety inspection is
really overdue.
Let me give you an example. Typical was this case that was
cited by the Chairman of the outbreak of hepatitis A attributed
to strawberries suspected of being of Mexican origin. Now,
which Federal agency was going to take a look at these
strawberries? Well, strawberries are regulated by the Food and
Drug Administration, except in this case, because these
strawberries were headed for the school lunch program, the U.S.
Department of Agriculture also had jurisdiction. Dueling
agencies, is that a good idea? I do not think it is. I think it
is a waste of resources and something we can certainly do
something about.
Consider eggs. An egg in the shell is under the
jurisdiction of the Department of Agriculture. A broken egg
falls within the jurisdiction of the Food and Drug
Administration. A pepperoni pizza, Department of Agriculture.
Cheese pizza, the Food and Drug Administration. Go figure. This
is how the laws are written in America and they do not make
sense. It is time for us to change them.
Let me also say that the limitations on the Food and Drug
Administration need to be examined. The Food Safety Inspection
Service of USDA has the authority to require exporters of meat
and poultry to the U.S. to have systems equivalent to ours. The
Food and Drug Administration does not have this authority. It
allows food imports from almost any country and takes on the
burden of ensuring the safety of imported foods only as they
arrive in the United States.
In 1997, about 2.7 million imported shipments of food were
received in the United States. The FDA inspected 1.7 percent of
those shipments. In 1997, administration initiatives on food
safety proposed the FDA be given equivalency authority, like
the Department of Agriculture. Senator Mikulski introduced S.
1707, which would achieve this, and I think it is a good thing
for us to do that.
As we see more and more imports, we have to ask whether the
system is on overload. According to GAO, in 1997, the number of
import entries per USDA inspector was approximately 1,645.
Contrast this with the Food and Drug Administration. The
average number of annual food shipments per FDA inspector was
approximately 10,555. Is it any wonder that they are missing
things? I think, frankly, that we have got to give them the
resources and the legal authority and then hold them
accountable for exercising that authority properly.
I am glad the administration has stepped forward in
enacting HACCP, a new standard which, frankly, will bring food
inspection in the United States into the 20th and 21st century.
I think this is something that has to be done with the
cooperation of both political parties and all agencies of the
Federal Government.
The legislation I have introduced to consolidate agencies
is not about more regulation, it is about effective regulation,
lower costs, and clearer goals. To mangle a metaphor, let us
step up to the plate together and make sure it is safe to eat
what is on it. Thanks.
Senator Collins. Thank you, Senator Durbin. Senator Levin.
OPENING STATEMENT OF SENATOR LEVIN
Senator Levin. Thank you, Senator, Collins, for your
leadership, for calling this hearing to discuss a very, very
critical issue, which is the safety of imported foods and also
the GAO's findings on the adequacy of our Federal Government
food inspection efforts. I commend the GAO for its thorough and
its well-reasoned report and look forward to their testimony.
Ensuring the safety of this Nation's public food supply,
whether domestic or imported, must be a top priority for our
government. In February, I introduced the Safe Food Plan Act to
emphasize food safety in the Department of Agriculture and to
create a food safety rapid response team within the agency to
react timely to food safety crises. Some important features of
that bill, including the establishment of the FEMA-like crisis
management teams to respond to foodborne illness outbreaks, are
incorporated in the Senate bill that we just passed, S. 1150,
the Agricultural Research Extension and Education Reform Act of
1998.
Based on the studies that I have seen, including this GAO
report, our laws have big gaps, the remedies that are in the
existing laws are woefully weak, and our enforcement is
understaffed, given the huge increase in imported food. We have
to reevaluate our inspection schemes for imported foods in
light of the statistics which Senator Durbin and others have
given showing the huge growth of agricultural imports to the
United States.
CRS estimates that over 33 million Americans get sick each
year from cases of foodborne illness, with over 9,000 deaths
resulting from those same cases of foodborne illness. The case
of Lindsey Donneth in Michigan comes to mind. She attends
school in Marshall, Michigan. Her mother, Sue Donneth,
testified before this Committee in February, relating the
incident in which her daughter, as well as hundreds of other
Michigan school children and teachers, contracted hepatitis A
from tainted strawberries that were imported from Mexico. They
were part of a strawberry shortcake that was part of a school
lunch program. While Federal law prohibits the use of imported
foods in the school lunch program, those strawberries somehow
or other made it into the program.
Lindsey Donneth experienced a horrific reaction to the
contaminated strawberries. She was hospitalized and she
continues to have significant heath-related problems as a
result of the incident.
In addition to the suffering and the other unquantifiable
costs that are caused to victims, our Attorney General, Frank
Kelly, has estimated that this single incident of tainted
strawberries in our school lunch program cost my home State
almost $1 million. That is the quantifiable cost, not the
suffering and the pain and the loss, just the dollar cost to
our State. Calhoun County's costs to combat this outbreak alone
were $150,000.
So we have major problems here with our food, our food
supply, and particularly our imported food, and I look forward,
Madam Chairman, to these hearings and again commend you for the
initiative which you and so many other Members of this
Committee, our Ranking Member, Senator Glenn, and Senator
Durbin and others have taken in this area.
Senator Collins. Thank you, Senator Levin. I know this is
of great personal concern to you, given the outbreak in your
home State.
Prior to this hearing, as Chair, I sent letters to 21
consumer and industry groups inviting them to provide written
statements on the safety of food imports. As of today's
hearing, not all of the statements have been received. The
hearing record will, therefore, be left open for 10 days so
that all statements can be printed in the record, and also,
without objection and for the convenience of Members, all
exhibits previously made available to the Subcommittee,
including the charts that we will use today, will be made part
of the hearing record.\1\
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\1\ Exhibits 1 through 19 appear in the Appendix beginning on page
64.
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In front of us today is an assortment of imported fruit
that the staff purchased last night at a Virginia
supermarket.\2\ Just to give you some idea in case the labels
are not clear, we have fruit from Mexico, Guatemala, Dominican
Republic, Ecuador, Belize, Costa Rica, South Africa, Chile, New
Zealand, Turkey, and Thailand. I think that is very typical of
what one finds in the marketplace nowadays.
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\2\ See Exhibit No. 2 that appears in the Appendix on page 65.
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Our first witness this morning is Dr. Mary Ellen Camire.
Dr. Camire is the Chair of the Department of Food Science and
Human Nutrition at the University of Maine and a recognized
expert on food safety. She has testified previously before a
House Committee as an expert witness on food safety.
She earned her A.B. degree from Harvard Radcliffe, a
master's degree from the University of Massachusetts, and her
Ph.D. from Texas Woman's University. She is the author of more
than 20 scientific papers and four book chapters on food safety
and we are delighted to have her here with us today.
Pursuant to Rule 6, all witnesses who testify before the
Subcommittee are required to be sworn in. It is not that we do
not believe you will tell the truth, it is part of our
procedures. So I will ask at this time that you rise and raise
your right hand.
Do you swear that the testimony you are about to give the
Subcommittee is the truth, the whole truth, and nothing but the
truth, so help you, God?
Ms. Camire. I do.
Senator Collins. Thank you.
Unfortunately, Dr. Camire has been stricken with
laryngitis, so we will do the best that we can, and if you need
more water at any point, please just motion the clerk. Senator
Glenn asked whether it is a result of a foodborne illness from
imported food. [Laughter.]
Please proceed, and bring the microphone as close to you as
possible and speak right into it. Thank you.
TESTIMONY OF MARY ELLEN CAMIRE,\1\ ASSOCIATE PROFESSOR AND
CHAIR, DEPARTMENT OF FOOD SCIENCE AND HUMAN NUTRITION,
UNIVERSITY OF MAINE
Ms. Camire. Thank you. First of all, I would like to thank
Senator Collins for inviting me to speak today and for bringing
this important issue to the forefront.
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\1\ The prepared statement of Ms. Camire appears in the Appendix on
page 47.
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My name is Mary Ellen Camire and I am Chair of the
Department of Food Science and Human Nutrition at the
University of Maine. I think food safety is a concern for many
Americans today. I would like to give you an overview of the
problem of the safety of foods brought into our country, first
looking at some of the more serious pathogenic disease-causing
microorganisms that have been found in foods and then
addressing some things that could be done to address these
issues.
Most of the pathogenic microorganisms that are found in
foods are really spread by contact with feces. It is not a very
appealing thought, but contact with feces is pretty much the
only way you can contract a foodborne illness. Human feces are
the highest risk because human diseases are more easily passed,
but animal feces also contain a number of pathogenic
microorganisms that can also cause human disease.
When we import foods from less developed countries, they
may have untreated sewage. This contaminates the drinking water
and it also contaminates the water used to irrigate fields and
wash produce in processing areas. When tourists are advised not
to drink the water, we do not stop and think that they are
using this same water to wash the foods that are then shipped
to our stores.
We also have a problem with sewage that is discharged into
the ocean in these countries, that oysters and clams and
mussels, shellfish, filter seawater, and in filtering the
seawater, they concentrate these microorganisms in them, and
when you go to eat them, they are just full of the bacteria and
viruses.
The problems with sanitary conditions in farm fields have
been a major hazard. One of the ways to reduce this risk is
hand washing by farm employees. This is not particularly easy
to do. Portable toilets may be available to workers, they may
not be, but since farm workers are paid by the piece, they do
not necessarily want to take the time to go to the portable
toilets and use the sanitation facilities there. They may or
may not have hand washing. They lose time, and time is money,
so they tend to just go right there.
Contamination from animal feces is a major problem, that
farms create huge piles of manure that they will eventually use
for fertilizer. When it rains or there are floods, the manure
will spread out over the farms and contaminate the produce.
You also have a problem with cats and farm animals and even
wild animals walking through the fields and spreading. We have
found deer and wild birds' feces contain many of the
microorganisms that give us illnesses.
The first microorganism I would like to discuss is
Cyclospora. Previously, this microorganism had only been
associated with drinking water. In fact, we only really heard
about it in the 1980's, so Senator Glenn was correct. We did
not know about this microorganism until the 1980's. No one
heard of it. Previously, it was only found in remote areas in
the drinking water. If you went hiking, you may contract it.
Guatemalan raspberries were associated with the 1996
outbreak that made almost 1,500 people ill in 20 States.
Cyclospora produces a very violent form of diarrhea, with
fever, cramps, vomiting, and other unpleasant symptoms that
occur within a week of ingestion. Although it can be treated to
some extent with antibiotics, it is not a bacteria, it is a
parasite. There is a possibility for fatal dehydration to occur
in very young children and very elderly patients.
There is not a simple test for this parasite. You can
screen patients and examine their feces for this microorganism,
but you cannot test food for this microorganism. There is not
an easy way. If a worker has this disease, there is no easy way
to test them other than collecting a fecal sample, and we are
not really sure right now of the effects of processing, such as
freezing and canning and blanching on Cyclospora. We do not
know if the microorganism survives the freezing process.
Another microorganism that has been associated with
imported foods is hepatitis A. FDA has classified hepatitis A
as a serious food hazard. It can survive in the environment or
on food surfaces for many weeks, is resistant to drying and
heating, and these are two of the methods we use to preserve
foods.
Hepatitis A is also spread through feces. Contaminated
water as well as food transmit the virus to the small
intestine, and then it goes from there to the liver, and then
it goes into the blood stream. You only need 10 to 100
particles to produce an infection.
What happens with shellfish is that they will filter this
in the ocean. Sewage is discharged in the ocean. It is easier
to collect the shellfish close to shore, where the sewage is
discharged, and they concentrate the virus. They are harvested,
they are shipped to market, and they are full of the virus.
Strawberries and salad greens have also been identified as
sources of contamination, and these require a fair amount of
handling. The strawberries must be hand picked and then they
are put in the boxes. So every time someone touches a berry,
there is a potential of contaminating that berry with hepatitis
A.
Salad greens also must be hand collected and then washed,
and there is a big trend now with the baby greens and the more
exotic greens, and those require, again, more hand contact,
which increases the risk of contamination. Mechanically
harvested crops, where you have a machine shaking the product
onto a basket, poses a much lower risk.
Hepatitis A is like other viruses, such as chicken pox, in
that once you have been exposed to it, you get an immune
response and that gives you immunity against repeated
infection. In these other countries, it is a common childhood
illness. In Mexico, inspectors went from the Centers for
Disease Control. Farm workers in the suspected farms were not
sick. Yes, they had hepatitis in their system, but they were
not obviously sick because they had had it as young children
and developed immunity. They did not get sick from it again.
It is fairly mild in children. Just remember, chicken pox
is always worse when you have it as an adult. It is the same
thing with these other viral illnesses. It is just milder for
children, that virtually all children in less developed
countries can be exposed to this and they develop immunity.
In 1997, over 150 people in Michigan became ill from eating
these frozen strawberries which were processed in California.
They were distributed in six States, but other States,
including Maine, received these berries. In California, the
children were immunized as a precaution. The company paid for
the immunizations. They needed to have two immunizations and
there was a cost of approximately $100 per student for the
immunization.
There are several forms of hepatitis, but another form that
may be a problem in the near future is hepatitis E. This is an
emerging disease in Asia, in Africa, and Mexico. This is also
spread through the fecal contamination of water and I
anticipate that this could be another foodborne illness in the
near future, and this is one for which we have no immunization
available.
A bacterial form of food poisoning that we will see is
salmonella. I think more people are aware of salmonella
poisoning. This is a traditional church picnic type of food
poisoning. The typical symptoms include vomiting, nausea,
diarrhea. It is sort of acute. You get it within a few days or
maybe a few hours of eating the food. The bacteria also can go
into the blood stream and cause severe infections, particularly
in the elderly and in individuals who already have another
disease.
There are several species of salmonella. Salmonella
enteritidis is one that we are seeing more and more associated
with eggs and poultry. This causes a severe infection, but we
also see one that causes what we used to call in the old days
typhoid fever, and that is salmonella typhi. This has a
fatality rate of 10 percent. So 10 percent of the people who
contact this disease will die from it. For most salmonella
species, it is only 1 percent.
People are familiar with salmonella, but I do not think
they realize the potential for fatalities. The elderly are very
susceptible to fatalities for any of these salmonella
infections. People in nursing homes and hospital patients are
particularly at risk because they may already have other
illnesses which have weakened their immune systems and they
cannot fight back.
Two large outbreaks of salmonella were traced back to
cantaloupes imported from Mexico in 1989, in 1991, and there
were several deaths associated with those outbreaks.
One of the particularly insidious things that occurs with
salmonella infections is chronic conditions. My youngest
brother contracted salmonella when we were children, and I can
tell you, it is not a pleasant thing to do. If you do not die
or have chronic symptoms, you have severe diarrhea and you
almost wish you were dying at some point.
Many people, within a few weeks after the initial bout of
the nausea and diarrhea is over, start developing a form of
arthritis that sets in. Many bacterial infections will cause
autoimmune disorders to develop, and for salmonella, we have
traced this back to arthritis pain.
The final species I would like to discuss is E. coli, and
particularly E. coli 0157:H7. E. coli is found in our
intestines and there are very different strains that have
developed in recent years. Two of these strains were associated
with imported foods, but E. coli 0157 we are familiar with the
Jack in the Box poisonings. This has been traced back to juices
and sprouts and a variety of other food products. It has not
yet been detected in imported foods, but American foods shipped
to other countries have been identified as a source of this
problem, so it goes both ways. American foods have also been
fingerprinted as being a source of contamination.
I notice that my red light is on.
Senator Collins. If you have a few more comments you want
to make, go right ahead.
Ms. Camire. OK. I just have a couple more comments.
Senator Collins. OK.
Ms. Camire. I believe that preventative measures at the
farm level are the best precaution, that inspections are not
effective because you cannot test every single shipment. In
many of these pathogens, we have no effective way of measuring
them in foods. So, therefore, inspection will not tell you
anything. To go back to the farm, make sure that the farm, the
processors are employing safe practices by the use of HACCP and
other practices. It is, I think, the best protection to the
American public.
In summation, I think without any further intervention, the
outlook for foodborne illnesses from imported as well as
domestic foods is not very good. New pathogens will continue to
develop. Using science to plan screening programs to improve
safety was efficient in terms of cost and manpower. We must
remember that imported foods are not the only problem.
The American public has changed. Americans are more
susceptible to foodborne illnesses. There are more individuals
with HIV, who have been treated for cancer, had transplants,
and more elderly people alive today. We must do more to educate
them on how to protect themselves against foodborne illness.
As a resident of a State that has a very short growing
season and relies heavily on imported food, I think it is time
that we ensure the safety of imported produce, in particular.
Thank you.
Senator Collins. Thank you very much, Dr. Camire. You have
certainly succeeded in spoiling our appetites for the rest of
the day. None of us will touch any fruit or vegetables.
[Laughter.]
In all seriousness, I really appreciate your coming forward
and helping us to understand the pathogens involved and just
how serious this issue is.
We are going to have 10-minute rounds of questions now, so
we will have the lights on for the Senators, as well.
As I mentioned earlier, my staff went to a local grocery
store and was able to gather some imported fruit that you see
before you on the table. Now, you are a trained scientist. You
are an expert on food safety. Can you just by looking at this
fruit, as you would in a grocery store, identify which ones are
tainted or possibly contaminated or pose a risk?
Ms. Camire. No. I could not tell you, just looking at them.
No one could.
Senator Collins. So it is not realistic to expect the
consumer to solve this problem. There is no way that the
average consumer could tell whether or not these fruit are
contaminated if you, a scientist and an expert could not, is
that correct?
Ms. Camire. Right. [Nodding head up and down.]
Senator Collins. Are there pathogens that could remain on
this fruit or vegetables even if the consumer rinsed it and
properly prepared the fruit or vegetable?
Ms. Camire. There have been some studies. This is an area,
in fact, that there has been very little research, but the
research that has been done shows that simply rinsing, which is
what most people would do, will not remove all bacteria.
And then you have a problem. You have got cut melons. If I
was going to point out something that might be a risk, it would
be those cut melons, because you cannot scrub them. If you have
a whole watermelon, you can scrub the outside pretty well. That
is what is going to be contaminated. But once somebody cuts it,
you do not know how well they have washed the outside of that
before they have cut the melon.
Senator Collins. So even if a consumer carefully rinses the
vegetables and fruit that the consumer buys, while it is a good
step to take, it is no guarantee that is going to make the
vegetable or fruit safe?
Ms. Camire. Correct.
Senator Collins. As we have mentioned earlier, the volume
of imported fruit and vegetables has soared in the past 5 years
and it is expected to increase even more in the future. Are
there any unique risks that are posed by imports that we should
be concerned about?
Ms. Camire. I think, in particular, any of the crops that
are hand picked, such as the berries and the leafy greens pose
a particular risk.
Senator Collins. Is there also an issue here because of the
sanitation methods in lesser developed or developing nations,
that they may not be equivalent to what we are used to in the
United States? You mentioned some of the hand picking and
sanitation process and your belief that you really need to cure
this problem at the farm.
Ms. Camire. Yes. I think what I have seen from the cases in
Mexico and Guatemala is that once the farmers realized what was
going on, they were able to institute practices that made the
food safer. But not all the farmers are aware of this. So if we
do a top-down approach and ask the governments of each country
to make sure that the farmers understand the practices and
follow through on them and provide adequate sanitation on their
farms, I think that is a big first step in securing food safety
from imported foods.
Senator Collins. Another problem posed by food imports is
that American consumers may not possess the natural immunity to
certain microbes that are common in developing countries. Is
that an issue, and do you foresee that certain viruses or
bacteria or parasites would pose particular problems to the
American consumer because we have not tended to be exposed to
them prior to the import of these fruit and vegetables?
Ms. Camire. Yes. There are certain ones, like hepatitis,
that you can develop immunity to certain viruses and some kinds
of bacteria. But the parasites, like Cyclospora,
Cryptosporidium, and Giardia, we are not sure yet. So it is
possible once someone is exposed, they can develop immunity,
but most Americans have not been exposed to it, other than
these imported foods, unless they have traveled extensively. So
as we import from more and more exotic locations, the
possibility that Americans will be exposed to more exotic
diseases is more likely.
Senator Collins. You mentioned in your testimony quite
explicitly that some of the symptoms associated with foodborne
illnesses are very serious. A lot of us tend to think of
foodborne illnesses as being a temporary bout, perhaps, of
nausea or diarrhea, but something that goes away. But are there
some chronic illnesses that have been associated with foodborne
pathogens?
Ms. Camire. Yes, there are. There are a number of bacteria
that have been associated with chronic health problems.
Yersinia, shigella, salmonella, Campylobacter, and E. coli can
lead to arthritis. Yersinia and giardia can cause a form of
autoimmune thyroid disease. E. coli 0157:H7, streptococcus, and
shigella can lead to permanent kidney damage. Toxoplasma, which
many people associate with having cats and pregnancy, will
cause birth defects, but can be also transmitted by food. And
worm parasites, which is something no one really likes to think
about, can cause permanent neurological damage. The worms, you
eat them and they migrate to your brain. Actually, in some
countries, that is the major form or cause of mental problems.
Senator Collins. You have mentioned also that the people in
the United States who are going to be most vulnerable are the
very young, people with compromised immune systems, such as
someone who has gone through chemotherapy or an AIDS patient,
and also the elderly. Are there any particular precautions that
those vulnerable populations could take?
Ms. Camire. I think it would be helpful for them to be
warned to be sure to wash the food thoroughly, to cook it if at
all possible, because cooking will reduce the risk for most of
these pathogens. But encouraging people to eat healthy foods,
fresh fruit and vegetables and fresh salads, and there is not
too much you can do to a fresh salad to really reduce the risk
other than rinsing it. So that is not help. But to let their
caregivers know, perhaps, to substitute canned fruit instead of
fresh fruit would reduce the risk.
Senator Collins. One final question for you. As we are
increasing our reliance on imported fruit and vegetables, as a
scientist, do you predict that we are going to see more
outbreaks of foodborne illnesses?
Ms. Camire. I do. I think we will be seeing more different
types of species coming into our food supply.
Senator Collins. Thank you. Senator Glenn.
Senator Glenn. Thank you, Madam Chairman. I have a couple
of questions and then I will turn the rest of my time over to
Senator Durbin. I know he has a long list of questions.
I want to know how people can protect themselves against
this. If you eat fruit or vegetables, let us say there is
nothing contaminated on the outside, but let us say the fruit
or vegetable grew in a contaminated soil. Just nature protects
us, does it not?
Ms. Camire. Yes.
Senator Glenn. The interior of that, the moisture inside,
will be OK. In other words, if I have an orange that was grown
in contaminated soil and I peel it and I do not get some of the
contamination on with my hands, that fruit inside is OK even
though it was grown in contaminated soil, right?
Ms. Camire. Correct.
Senator Glenn. Well, then, things that we eat in their
entirety, though, with the shell or whatever on it, like
lettuce, or the exterior of it that we eat, can you protect
yourself to some extent by putting this not only in water but a
tiny amount of Clorox or something like that in to wash it? Can
we do that with cantaloupes and melons and all sorts of things
to kill whatever is on the outside? Just for people that may be
watching this or possibly somebody who might even read the
hearing transcript someday, what do they do? What is the ratio
that they can use?
Ms. Camire. I have not done it lately, but I believe it is
about a tablespoon in two gallons of Clorox. It is not a lot.
One of the concerns, however, chlorine is very effective in
killing microorganisms, but there has been a lot of concern
that the chlorine will also produce carcinogenic compounds, so
it is sort of a no-win situation. But at this point, I would
say that the risk of the microbes is worse than the risk from
the carcinogenic compounds.
Senator Glenn. But could people use that and then wash the
chlorine off in fresh tap water? How long do you have to leave
it in to kill these little bugs?
Ms. Camire. Oh, at least 10 minutes.
Senator Glenn. Ten minutes?
Ms. Camire. Commercial enterprises in this country do that
for the fresh salads.
Senator Glenn. Wash them well in about a tablespoon or two
of chlorine per two gallons of water, about what you would fill
up a sink with, I guess, put a couple tablespoons of Clorox in
and wash them or let them sit in there for 10 minutes or so and
then wash them off with tap water----
Ms. Camire. Plus it may not taste as good.
Senator Glenn [continuing]. Because I do not think you want
to drink chlorine. Would that be something people could use to
protect themselves?
Ms. Camire. Yes, and I think more and more people are, and
to use a scrub brush will do a lot, because you have to
physically remove them. But even a mild detergent, because a
detergent makes it slippery and the bacteria cannot stick as
well.
Senator Glenn. Is there anything besides Clorox or
something like that? Is there any other thing as good in this
regard?
Ms. Camire. No. We have not found anything yet. Now,
natural preservatives, salad dressings and fruit and jams will
stay is because bacteria do not survive well in acid
conditions. Unfortunately, the bacteria are mutating and they
are becoming resistant to acid, becoming resistant to salt,
they are becoming resistant to many of the anti-microbial
compounds we put in to preserve foods. So we are running out of
options.
Senator Glenn. I think my wife, Annie, is going to have to
get a new bottle of Clorox because we are going to start using
that at home, I think. [Laughter.]
I have just one other question. How does inspection of
domestic products differ from inspection of imported products?
Is there a major difference in the way they are inspected, or
is it that we just do not do enough of them? Are they basically
the same inspection?
Ms. Camire. I am not really an expert on the inspection
process, but I believe they are very similar. But the problem
is, you cannot see these things on the food.
Senator Glenn. Are there any other things we can do at
home? The fruit on display this morning looks great. I wanted
to get a spoon and dig into this a little while ago and I
looked over here----
Senator Collins. We would be glad to give them to you.
Senator Glenn. I do not think I will. We may want FDA to
check them out first before we do that. That would have been a
neat deal, too, to have FDA see which ones are contaminated
here.
Is there anything else we can do at home besides just
scrubbing or Clorox or things that protect us at home, because
we are not going to stop eating these things.
Ms. Camire. I think to make sure that you are keeping it
cold, because cold will slow down the growth of most of these
microorganisms and that will help it, not to go to the farm
stand and buy it and then keep it in the car while you do your
other errands, because that allows them to grow even faster.
Senator Glenn. Thank you. I yield the rest of my time to
Senator Durbin.
Senator Durbin. I yield to Senator Levin.
Senator Levin. Thank you both. I have a bill coming up on
the floor that I have to manage. Thank you.
The Food and Drug Administration, as I understand it, does
not have authority for these kinds of fruit and vegetables
coming from countries to say they cannot come into the United
States unless those countries have equivalent protections to
the United States. Our Agriculture Department does have that
authority relative to meats, but the FDA does not have that
authority relative to fruit and vegetables.
Now, we have a whole list of countries here on the
Chairman's list \1\ and my question is this. Is there any
reason why we, as a Congress, should not give to FDA the same
authority to stop products from coming in, vegetables and
fruit, which come from countries that do not have equivalent
protections to ours that our Agriculture Department has
relative to meat coming in? Should we not do that?
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\1\ See Exhibit No. 2 that appears in the Appendix on page 65.
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Ms. Camire. We should give them that authority. Obviously,
we have not had any outbreaks of foodborne illness recently
traced back to imported meats or poultry.
Senator Glenn. So is it working with meats and we ought to
do the same thing with other imported food products?
Ms. Camire. It is working with those products.
Senator Glenn. I think so. Thank you very much, and thank
you, Madam Chairman.
Senator Collins. I am going to turn to----
Senator Domenici. That is fine. I was here late. Go ahead.
Senator Collins. Senator Durbin.
Senator Durbin. Thank you very much.
Dr. Camire, you have given us a lot of food for thought.
[Laughter.]
So we should scrub our watermelons, run our salads through
a bleach process, and put the cantaloupes in the washer? I
understand that we have to take it seriously, it is a serious
subject, but it is quite a departure from what people
ordinarily do in their homes and kitchens, and I take it that
since this is your field, that this is a practice that you
recommend?
Ms. Camire. Yes. When I was in school, we never even
considered these as being a problem. It was not a problem. You
worried about meat, dairy products and eggs being sources of
foodborne illness, not fruit and vegetables. So we are going to
have to reeducate consumers on how to protect themselves. But I
think a more effective thing is to make sure that we are
getting safer food into the system.
Senator Durbin. You have discussed a lot of--and forgive
me, I am a liberal arts major, so hang with me for a minute
here--you have discussed a lot of bacteriological-related
illness, and there are other elements that are part of this.
For instance, when I visited with the Food and Drug
Administration, one of the things that they were looking for
was the improper application of agricultural chemicals, the
drift of pesticides and insecticides and other things from
perhaps an apple orchard to strawberries or watermelons and the
like, and that presents a whole different range of challenges,
does it not?
Ms. Camire. Yes, it does.
Senator Durbin. Let me try to put this in a context,
though. Let me give you a hypothetical. Let us assume for a
minute that we took anything from this table, the grapes or
whatever it happened to be, and brought it to you in your
laboratory and said, is there anything wrong with this? Tell
me, just in summary, how long would it take you to establish
and come back to me and say, there is nothing wrong with it. We
have tested it. We have tried everything we can think of that
might be a danger to you as a consumer. How long would it take
you to go through the procedures to reach that conclusion?
Ms. Camire. First of all, we could not guarantee complete
safety, but to look for specific pathogens in pesticides would
take at least a week.
Senator Durbin. So a week, but----
Ms. Camire. By then, it would be spoiled.
Senator Durbin. By then, it would be spoiled, but we would
have to give you a clue going in. We would have to say, we
suspect that there is something on these grapes that may be
related to one of the things you mentioned, whatever it
happened to be, and then you have a clue, and then, in the
course of a week, you will be able to test it and report back
to us as to whether or not it might pose a danger or not, is
that correct?
Ms. Camire. That is correct, and there is also no test
available for many of the foodborne pathogens yet.
Senator Durbin. So you need a clue, there are no tests
available for some of the problems, and it would take you a
week to do it if we had given you that clue. Now, what if you
do not have a clue? What if you were an FDA lab and we have
just handed you these grapes and said, are these safe to sell
in America? How long would it take you to consider all the
possibilities that might be dangerous to American consumers?
Ms. Camire. In reality, it might take several weeks,
because with the bacterial testing, you sort of grow the
bacteria and then try to spread out and see what is in there,
and some of these things just do not grow very well in the
conditions that we have traditionally used for microbiology.
Senator Durbin. So when we are dealing with perishable food
and we want to be completely safe, the honest answer is, you
cannot be completely safe.
Ms. Camire. Correct.
Senator Durbin. The second question I have to ask you is,
what kind of equipment is necessary for you to go through this
testing process? Again, forgive me for not remembering it, but
when I went to Los Angeles to the FDA lab, after they have
broken down the sample and ran it through this chemical test,
they had a range of different chemicals they were looking for
to see if chemicals had been improperly applied, and there was
some sort of spectrograph, does that sound right?
Ms. Camire. Yes.
Senator Durbin. I cannot believe I remembered that. There
was a spectrograph, and they would look for this range of
chemicals to see. Now, give me an idea of the equipment
necessary in a laboratory to test for the different illnesses
and problems which you have told us about.
Ms. Camire. For the microorganisms, it is not really
sophisticated equipment. It is more traditional incubators and
heaters, more supplies more than anything else. But then you
also have to take steps to make sure that the staff do not get
contaminated and you have to have special hoods that will keep
the bacteria from blowing back. It is more protecting the staff
than anything else.
But I would like to make a point. My concern right now,
because we do a lot of pesticide testing in my department,
pesticides, we are really not sure how dangerous they are. They
may kill you in 20 years. Some of these illnesses will kill you
in 2 days.
Senator Durbin. Could you give me some kind of an estimate
of what a well-equipped laboratory might cost today to be
prepared to test fruit and vegetables and other food products
that are coming in so that you could say with some reasonable
scientific certainty that products are safe for consumers? What
are we talking about, a range, if you will? I am not going to
hold you to an exact figure.
Ms. Camire. I would say easily a half million dollars to a
million dollars.
Senator Durbin. And, of course, a lot of personnel who
would also be involved.
Ms. Camire. Yes.
Senator Durbin. How many people would work in a lab like
that usually?
Ms. Camire. I would say at least a dozen, and the problem
is, we are not training scientists fast enough to meet the
demand.
Senator Durbin. The reason I raise that question in that
context is to give some indication of the challenge that has
been placed before us as a Nation and whether we can meet it. I
think from your testimony there is a serious question as to
whether we can meet this challenge. If Americans want to
continue to eat a variety of fruit and vegetables, many of them
exotic and not indigenous to the United States--and, I might
add parenthetically, we cannot assume everything grown in the
United States is safe, but certainly those imported have raised
a lot of concern--then you have kind of put it in a very
important context for us.
There is a limit to what science can tell us. There is a
limit to the period of time that science can give us the
information and it be of any value while the fruit and
vegetable is perishing. It is an expensive investment in terms
of equipment and people for us to do this, and we are taking it
beyond the context of a bunch of grapes that I have just handed
you and putting it in the context of literally millions of
shipments of imported fruit and vegetables coming into the
United States.
I asked the staff to come up with some information about
how Congress has been funding the activities here for food
safety at the Food and Drug Administration. There is a line
missing from the graph over there that would be interesting,\1\
and that is the Congress' funding of inspectors for food safety
during the same period of time. We have seen a dramatic
increase in imports. We have seen a dramatic decline in
inspections. We would also see that during this same period of
time, the number of people that Congress has paid for to do
this job has basically been flat-lined, that we have not seen
any type of increase in personnel. I probably would see the
same thing holds true when it comes to equipment in these
laboratories.
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\1\ See Exhibit No. 1 that appears in the Appendix on page 64.
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So if we are serious about this and if we really want to
give the consumers some kind of assurance, then we are going to
have to make an investment to make that happen in terms of
well-trained people, and in terms of equipment. I do not know
if we are prepared to do that in the context of a balanced
budget and tax breaks and whatever else we decide to spend our
money on. I am not sure we are prepared to do that.
But I thank you for your testimony. It has been very
valuable.
Senator Glenn. If you would just yield for one question.
Senator Durbin. I would be happy to yield.
Senator Glenn. I have just one question. You mentioned the
pesticides. Will the chlorine rinse neutralize those
pesticides, because they can have a bad impact on their own.
That would be a very much more complex chemical reaction, I
guess, with the pesticides.
Ms. Camire. No. In fact, if anything, it would probably be
the chlorine would make the pesticides worse.
Senator Glenn. The what? Would you say that again?
Ms. Camire. The chlorine would make the pesticides worse,
if anything. But no, there is not too much we can do about
neutralizing pesticides on the foods.
Senator Glenn. Do you want me to tell Annie to cancel that
buy on the chlorine? [Laughter.]
You gave me a solution, then took it away.
Ms. Camire. In the trade-off, those fruit and vegetables
contain many phytochemicals that prevent cancer. So the
chemicals in the foods themselves may protect against the
pesticides, but there is nothing in the food to protect against
pathogens.
Senator Glenn. Thank you.
Senator Durbin. Thank you.
Madam Chairman, one last thing I would like to point out
for the record, I asked for a history of the FTEs, the full
time equivalent employees, at the Food and Drug Administration
in the Food Safety Resources Section based on the amount of
money appropriated by Congress. In 1993, there were 2,636. If
you put it on this chart,\1\ you can get an idea. During the
period of time when the FTEs decreased from 2,636 in 1993 to
2,154 in 1997, food imports basically doubled. That is an 18
percent decline in the people doing the inspecting while the
imports doubled. So if we are going to meet this obligation, it
is going to be a substantial one, and I am glad that the
Chairman of the Budget Committee is here to hear that.
[Laughter.]
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\1\ See Exhibit No. 1 that appears in the Appendix on page 64.
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Senator Collins. Senator Domenici, that is your cue.
Senator Domenici. Yes. I wanted to come this morning to
congratulate you, Madam Chairperson, for taking up this issue
last June. Before anybody else was involved, you saw a problem,
and I think before you are finished, something very
constructive will come of this. My understanding is you started
being concerned when we had the problem with Mexican
strawberries, is that not correct?
Senator Collins. That is correct.
Senator Domenici. That was May or June of last year. I
commend you for that.
For me, it is just a welcome reprieve to come down here and
be party to a hearing like this. Where I have been the last few
days, I wish on no one. [Laughter.]
Senator Domenici [continuing]. Trying to negotiate an ISTEA
bill with the House with 3,000 special projects that they want.
Excuse me. I did not know the TVs were on here.
Senator Durbin. Now you are in trouble. [Laughter.]
Senator Domenici. Well, I have told them that, too, that I
did not think that was a very good way to do business, but I
might not win on that.
Let me ask, what makes a particular food product a high
risk food?
Ms. Camire. One that is handled a lot, like berries, that
is hand picked. One that you cannot rinse very well, like a
raspberry is very soft, so you could not scrub it, whereas an
orange, you could scrub very well. And shellfish are a
particular problem. I would not say the fin fish and crabs and
things were quite as big a problem as the shellfish in terms of
seafood. But certain crops, things that are low to the ground,
it is easier for them to be contaminated with feces than
bananas up in a tree.
Senator Domenici. I think you testified earlier that the
country of origin labeling is not a food safety issue, in your
opinion.
Ms. Camire. No. I believe it is more of a consumer
information. Many people want to buy American and not everybody
realizes that we cannot produce those crops year around. We
think California can do everything for us. But I do not think
that necessarily there has been any indication to show that any
of these outbreaks have been traced back, that every farm in
that country has had that disease on its produce. It has been
with respect to a few farms in each country. Therefore, knowing
which country it is from, there may be farms that are following
very good practices, but they get penalized as well as the bad
farmers.
Senator Domenici. Thank you very much. I have no further
questions.
Might I say to you, Dr. Camire, I am very pleased to hear
you testify today and to note that you have chosen the
profession you have chosen. We have an academic system in
America that produces marvels in terms of what it excites
people to do, and clearly, we need more people like you. I
mean, you are off in your laboratory system, but you are able
to share some very important information from time to time with
your national policy makers. I am sure you do a lot of other
good research and I commend you for that.
Ms. Camire. Thank you very much.
Senator Collins. Thank you very much, Senator Domenici. We
appreciate your tearing yourself away from ISTEA negotiations
to join us. Feel free to stay as long as you can.
Senator Domenici. Thank you. Thank you.
Senator Collins. Senator Akaka, welcome.
OPENING STATEMENT OF SENATOR AKAKA
Senator Akaka. Thank you very much, Madam Chairman. I want
to congratulate you and commend you for having this hearing,
because it is so important to the health and welfare of the
people of our country. I also want to commend your staff for
providing such good material for us. I know, too, that this
will result in some changes that will help the people of our
country.
Dr. Camire, I am sorry I did not hear all of your
statement, but I was interested very much in this subject. I
know Senator Durbin would be, too, because he has been to
Hawaii, where we grow papayas, mangos, and pineapples, as well.
Over the years, the latter years, Hawaii has not been able to
compete because of the costs of labor, but we always feel that
our quality is good. We are part of the United States, so we
come under all the laws and policies that dictates how you
should treat fruit and vegetables. So whatever comes from
Hawaii, I guess I would say, would be safe.
We have always been concerned about how foreign countries
produce their fruit and vegetables and how they send it in to
us. One concern that I have, and I think you mentioned it, was
when it does come from a foreign country and we think it has
been treated with pesticides, how do we or the people who
handle food handle this? Do they just put it on a plate and
send it to you to eat, or do they treat it somehow? Do they use
chlorine? And who does this? Do the restaurants, the hotels,
use a system of cleaning it up before it is served?
Ms. Camire. It varies tremendously. Some of the importers
will do some cleaning. Some of the processors will do some
cleaning. But none is mandated, so it could come directly from
the field in another country, directly to the grocery store and
directly home to your kitchen table without any further
treatment.
Senator Akaka. I see. If they did treat it, one of the
treatments is to use chlorine, is that correct?
Ms. Camire. Yes.
Senator Akaka. Do the restaurants, do you know, use
chlorine to wash or clean vegetables?
Ms. Camire. Some do, more and more. There is a concern
about the taste, but they do use it. I think, unfortunately, a
lot of people rely on tap water having enough chlorine and it
does not have enough. But it is done to some extent in
restaurants, though I do not think they do that industry-wide
as a practice.
Senator Akaka. If they do use chlorine, would there be any
risk to the diners if they use chlorine to clean vegetables
that are used in salads?
Ms. Camire. There is a concern in California and in Europe
that chlorine does produce compounds that are carcinogenic.
But, as I say, I am looking at immediate risk versus a long-
term possible risk, and in terms of the scientific-based risk
assessment, I think it is more important to kill the
microorganisms. I choose my poison.
Senator Akaka. We are very, very concerned about this and
that is why I commend the Chairlady here for having this
hearing. It may be necessary that we should have policies or
regulations that would require that vegetables or fruit that
come from foreign sources can be cleaned before they are placed
on the plate for diners. Thank you very much.
Senator Collins. Thank you very much, Senator.
Thank you very much, Doctor. We really appreciate you
sharing your expertise with us today. Especially given your
laryngitis, we very much appreciate your willingness to strain
your voice in order to educate not only us but the American
public.
I would now like to call forward our second witness this
morning. He is Robert E. Robertson, who is the Associate
Director of Food and Agriculture Issues at the U.S. General
Accounting Office. Accompanying Mr. Robertson is Keith Oleson,
who is also from the U.S. General Accounting Office.
Mr. Robertson has been examining the issue of food safety
for at least 10 years. Today, he will present the results of
the GAO's study on the adequacy of Federal efforts to ensure
the safety of food imports.
I want to begin by complimenting Mr. Robertson and your
staff for your excellent report. It was extremely well
researched and we appreciate the amount of work that you have
done in this area.
As I have explained, pursuant to Rule 6, all the
Subcommittee witnesses do need to be sworn in, so I would ask
that you stand and raise your right hand.
Do you swear that the testimony you are about to give to
the Subcommittee is the truth, the whole truth, and nothing but
the truth, so help you, God?
Mr. Robertson. I do.
Mr. Oleson. I do.
Senator Collins. Thank you. You may proceed, Mr. Robertson.
TESTIMONY OF ROBERT E. ROBERTSON,\1\ ASSOCIATE DIRECTOR, FOOD
AND AGRICULTURE ISSUES, U.S. GENERAL ACCOUNTING OFFICE;
ACCOMPANIED BY KEITH OLSON, SAN FRANCISCO REGIONAL OFFICE, U.S.
GENERAL ACCOUNTING OFFICE
Mr. Robertson. Thank you, Madam Chair, Senator Durbin, and
Senator Akaka. I am happy to be here this morning to talk about
our work on imported food safety.
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\1\ The prepared statement of Mr. Robertson appears in the Appendix
on page 54.
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I will just reintroduce Keith Oleson. He is with our San
Francisco Regional Office. He has been involved with food
safety issues for years and he is intimately involved with the
work that we have just completed. Senator Durbin, like you, he
has accompanied inspectors and knows of what he speaks.
I will go ahead and summarize my statement and ask that the
full statement be put in the record.
Senator Collins. It will be put in the record. Thank you.
Mr. Robertson. Madam Chair, because imported foods play an
increasingly significant role in the Nation's food supply, it
comes as no surprise that the safety of the food consumed in
the United States is in part dependent upon the safety of these
imported foods. My comments this morning will highlight
findings from our recent report,\2\ which concludes that our
system for keeping unsafe imported food from entering the
United States has a number of weaknesses which we think can and
should be addressed.
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\2\ See Exhibit No. 3 that appears in the Appendix on page 66.
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Let me begin by noting that there are two Federal agencies
that are primarily responsible for the safety of imported
foods. USDA's Food Safety and Inspection Service, which I will
be referring to from this point on as FSIS, is responsible for
the safety of meat, poultry, and some egg products, and the
Food and Drug Administration is responsible for all other
foods. These two agencies coordinate their efforts with the
Customs Service and Centers for Disease Control.
Our recently completed review of FSIS' and FDA's efforts to
ensure the safety of imported food highlighted weaknesses in
three basic areas. First, FDA lacks the authority to require
that countries exporting foods into the United States have food
safety systems that are equivalent to ours. This is an
authority that FSIS has and uses to share the burden of
ensuring safe foods with exporting countries. Without such
authority, FDA relies almost exclusively on its port-of-entry
inspections to identify unsafe foods and stop them from
entering our food supply. As was pointed out earlier,
inspections in 1997 accounted for less than 2 percent of the
shipments coming into the country.
The second area of weakness that we identified involves
ineffective targeting of port-of-entry inspections. More
specifically, we found that FSIS and FDA could make more
effective and efficient use of port-of-entry inspection
resources by better targeting shipments for inspections that
posed the highest food safety risk.
To truly appreciate why it is so important that FDA and
FSIS deploy their inspection resources with great care, you
only need to look at the statistics on the number of shipments
arriving at U.S. ports. Last year, for example, FDA was
responsible for determining which of 2.7 million shipments
should be inspected, while FSIS was responsible for making
similar decisions on about 118,000 shipments.
We found that both agencies could improve decisions on
which shipments to inspect by better using available health
risk information. For example, to help its inspectors make
informed decisions, FDA has databases containing information
on, among other things, imported foods that have histories of
safety violations and the results of FDA laboratory tests
conducted on inspected foods. Unfortunately, these systems are
not well integrated and they are awkward to use. As a result,
inspectors often do not use the information and instead rely on
their own memory and their personal judgment.
In addition to making better use of existing health risk
data, FDA could further improve its inspection targeting by
improving its guidance to inspectors concerning which shipments
to select for inspection and by taking enforcement action when
importers are found to inaccurately describe the contents of
their shipment.
The third and final area of weakness that we found related
to the lack of control that FDA and Customs have over goods
arriving at U.S. ports. Weaknesses in these controls in some
cases allows unsafe products to enter the Nation's food supply.
Under current procedures, importers are allowed to retain
control over shipments before they are released. If importers
move shipments into domestic commerce without an FDA release,
and what I mean here is before FDA inspects them or when FDA
laboratory tests reveal that the products do not meet U.S.
standards, FDA has no effective means of requiring importers to
return the shipments for inspection, destruction, or reexport.
For example, in Operation Bad Apple, which took place in
San Francisco last year, Customs officials identified 23
weaknesses in the controls over imported shipments. In this
investigation, Customs found that about 40 percent of imported
foods determined to violate U.S. standards were never
redelivered to Customs for destruction or export. Additionally,
for about half of those that were redelivered, other products
were substituted for the original product. Now, what this means
is about 70 percent of the products that were ordered returned
because they were unsafe are presumably in commerce.
We also found other weaknesses in the controls over
imported shipments beyond those identified in Operation Bad
Apple. For example, when FDA requires an importer to provide
evidence that a suspect shipment is safe, the agency allows the
importer to select the laboratory that picks the samples and
conducts the tests. This has raised concerns over whether or
not some importers are able to falsify test results in order to
obtain FDA's approval to release foods into commerce.
Finally, FDA's and Custom's principal deterrent for
ensuring that importers comply with U.S. requirements, and that
is the collection of damages from violators, is uneven and
uncertain. For example, in 1997, Customs in Miami assessed
damages for only about 25 percent of the identified cases
involving improper distribution of food products.
Madam Chair, that is, in a nutshell, a summary of our past
work. If I am given a couple more minutes, I can run through
the two charts that we have here to give you a flavor of the
scrutiny that shipments coming into the United States
receive.\1\
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\1\ See Exhibits No. 4a. and 4b. that appears in the Appendix on
pages 130 and 131.
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Senator Collins. That would be helpful. Please proceed.
Mr. Robertson. Let us start with FDA, because that is a
little more complicated. Starting at the top of the chart, you
will see that there is about, as was mentioned earlier, 2.7
million entries in 1997 that arrived at U.S. ports.\2\
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\2\ See Exhibit No. 4a. that appears in the Appendix on page 130.
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If you go down to the next level, you see that about 56
percent of these 2.7 million entries were automatically
released by a Customs Service computer after that computer
basically analyzed information on these shipments.
If you move down to the next level, you will see that an
additional 42 percent of these entries were released after an
on-screen review by an FDA inspector.
Senator Collins. If I could just interrupt you to clarify,
so 56 percent were just automatically released without a visual
inspection or without any kind of review at all?
Mr. Robertson. There was basically a review by the Customs
Service computer on information pertaining to that shipment,
but there was no visual review.
Senator Collins. And that contrasts to what you are going
to tell us with FSIS, where there is a visual review of every
shipment.
Mr. Robertson. Yes.
Senator Collins. Please proceed.
Mr. Robertson. Actually, this is a good time to pause,
because even after the on-screen review by the FDA inspector,
what we are talking about is a total of, if my math is correct,
98 percent of the entries have been released without visually
inspecting them by anybody. These are all released through
computer reviews, through document review, that type of thing.
So now we are down to the final 2 percent on the very
bottom of the chart, 1.7 percent basically were physically
inspected or had some type of laboratory analysis performed on
them by FDA, and you will notice there is another block on the
bottom that talks about entries detained automatically because
of prior violations. This 0.3 percent also had some laboratory
analysis performed, but it was not performed by FDA. It was
performed by private laboratories that were selected by the
importers.
So that is a quick overview of what takes place in the FDA
inspection system.
If we move to the USDA or FSIS system, it is a little
simpler to run through.\1\ As I said earlier, in 1997, they had
roughly 118,000 food entries coming across the border, and
remember that all of these entries came from countries whose
food safety systems were certified as equivalent to ours.
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\1\ See Exhibit No. 4b. that appears in the Appendix on page 131.
---------------------------------------------------------------------------
Now, the thing to remember here, as you pointed out
earlier, is 100 percent of these entries at least were visually
inspected by USDA inspectors for transportation damage,
labeling problems, that type of thing.
After that initial examination, basically, the information
on those entries is run through a USDA computer, which
automatically selects which shipments need to be sampled, and
as the chart shows, about 80 percent of the shipments are
released and 20 percent are analyzed either by lab or have some
further inspection by a USDA inspector.
The bottom line is of the total 118,000 or so shipments
that came in in 1987, about 5 percent were rejected. So again,
that is just a quick summary of the two processes and the
differences in the two processes.
With that, we will be happy to answer questions.
Senator Collins. Thank you very much, Mr. Robertson. Again,
I want to commend GAO for its excellent work in this area.
It seems to me that you have identified two issues for us
to think about. The first is whether the FDA needs an expansion
of its legal authority in order to have the same sort of
equivalency system that helps protect us in the case of
imported meat, poultry, and egg products, that the FSIS has.
But the second issue is whether the FDA, to a greater extent,
but both agencies are targeting their resources effectively and
making the most effective use of what they have now. Is that
correct?
Mr. Robertson. That is correct.
Senator Collins. In your review, did you find a problem
with the FDA not focusing its resources on those imports that
posed the greatest health risks?
Mr. Robertson. Yes. I mean, we found problems, frankly,
with the way that both FDA and USDA distributed their
inspection resources at the ports of entry. From an FDA
perspective, the problems we found were that FDA did not give
its inspectors adequate guidance to help them select which
shipments they should be inspecting and which shipments they
should not be inspecting.
We also found that the tools that were available to
inspectors to help guide their decisions on what shipments to
inspect left a lot to be desired. What I am talking about here
is that these inspectors rely in part on several information
systems to help them make their selections and these
information systems were not well integrated. As a result, they
were difficult to use by the inspectors, and some inspectors,
as I said earlier, did not use them.
The third area of problems that we found in regard to the
way FDA was doing business at the port-of-entry inspections had
to do with their inability or their problems with assuring the
accuracy of information that importers submitted on shipments
that were coming through the border. Now, the reason that this
is important that this information be accurate is that it is
the information that USDA relies on to choose the shipments to
inspect.
So from an FDA perspective, those were the key problems we
found in regard to the way they were allocating their
resources.
Senator Collins. I am very alarmed by the results of
Operation Bad Apple, where in this select case, some 70 percent
of the shipments that had been pulled by the FDA as being
suspect nonetheless made its way to the American marketplace.
Is that an accurate description of what happened?
Mr. Robertson. Yes, that is accurate.
Senator Collins. How can that happen? Walk us through what
are the weaknesses that would allow tainted imported food
products, that have been targeted by FDA--this is a case where
they have actually caught it, despite the low inspection rate,
despite the clearing that is done automatically--and yet 70
percent of the shipment found its way to the American
marketplace anyway. How can that happen? What are the
weaknesses in the current system that allow that?
Mr. Robertson. Under the current system, basically,
importers of FDA-regulated goods retain control over their
shipments as the shipments come in and go through the border
crossings. They are supposed to----
Senator Collins. And if I could just interrupt, that is in
contrast to what FSIS does, is that correct, where in the case
of the Department of Agriculture, if there is a suspect
shipment, the Department of Agriculture takes custody of it.
Mr. Robertson. Right.
Senator Collins. But in FDA's case, the importer retains
custody?
Mr. Robertson. Yes. Maybe the easiest way to approach this
is just to talk about the two or three biggest differences
between the way USDA operates its system and the way that FDA
operates its system.
As you correctly pointed out, when a shipment comes in for
USDA inspection, those shipments are held in a USDA-registered
warehouse until they are released to go across the border. From
the FDA perspective, basically, as I said earlier, importers
retain control over those shipments.
A second difference in the controls between the two
agencies' systems has to do with the fact that FDA performs all
of its laboratory analysis, whereas, as I mentioned earlier,
under certain circumstances--did I say FDA? I meant USDA
performs all of its own laboratory analysis, whereas under
certain circumstances, FDA allows importers to choose the
laboratories where its samples are going to be analyzed.
And a third fundamental difference between the two
operations has to do with the control that they have over the
goods; has to do with what happens when goods basically do not
meet standards. In USDA's case, the goods are stamped ``Refused
Entry,'' with the hope that they will never be confused with
any other products. FDA does not do this.
Senator Collins. Why does not the FDA stamp the shipment
``Rejected,'' the way that the Department of Agriculture does?
It seems like such a simple step that could be taken to ensure
that rejected shipments do not get re-exported.
Mr. Robertson. What they have told us is that they do not
have the authority to do that.
Senator Collins. The FDA is arguing that it does not have
the authority to actually stamp a shipment ``Rejected''? I do
not know whether you are an attorney or not----
Mr. Robertson. I am not an attorney.
Senator Collins. Does that not seem unlikely to you? Is
that not a normal regulatory power that an agency would have?
Mr. Robertson. All I can do is tell you the explanation
that they gave us, which was they do not have authority to do
that.
Senator Collins. We will explore that with the FDA.
So, essentially, what you are telling us is that if a
shipment has been targeted by the FDA because there is reason
to believe that it may be tainted, the importer controls the
shipment, selects the sample for the laboratory analysis,
selects the lab that is going to perform the analysis, and the
FDA is relying completely on the integrity of the importer?
Mr. Robertson. The only modification I would make to that
is to make sure that when we are talking about selecting
samples, selecting the lab, that we are talking about those
goods that were automatically detained.
Senator Collins. Correct.
Mr. Robertson. Yes.
Senator Collins. Does that not invite problems by an
unscrupulous importer?
Mr. Robertson. It does not protect you against problems
that could be caused by that type of an importer.
Senator Collins. It would also be possible for the importer
to mis-enter into the data system what the product is and,
thus, avoid detection that way, is that correct?
Mr. Robertson. That is possible.
Senator Collins. Is this system pretty easy, then, for an
unethical importer who has tainted product to avoid detection
altogether?
Mr. Robertson. Let me put it this way. We went to about six
locations and we found evidence of weaknesses in these controls
at most of those locations. So the short answer to your
question is, it is relatively easy.
Senator Collins. I would like to turn to a chart that was
in your report on page 47.\1\ It listed some of the major
outbreaks that we have experienced in recent years. I was
interested to note that the outbreaks that are listed are
associated with fruit and vegetables or seafood that is under
the jurisdiction of the FDA. Does that suggest to us, and the
other findings in your report, that the Department of
Agriculture's system does provide more protection to consumers
than the FDA's process?
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\1\ See Exhibit No. 3 that appears in the Appendix on page 66.
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Mr. Robertson. I would suggest this, that from our
perspective, USDA has a better approach to ensuring safety
because it does rely in part on assuring that countries that
are exporting foods into the United States have systems that
are equivalent to ours, whereas FDA does not have that same
assurance. So from that perspective, I think that the design of
USDA's system is stronger than that of the FDA's system.
Senator Collins. I want to turn to the issue, again, of the
non-health-related risks of some of these foods that have been
targeted for inspection. Your report was critical of both
agencies for targeting its inspections based on non-health-
related risks. Could you expand on the kinds of risks? Are you
talking about, for example, missing labels as opposed to
tainted foods?
Mr. Robertson. Sure. We are talking about missing labels,
we are talking about incorrect weights, we are talking about
mislabeled, that type of thing, more along the lines of
economic-type considerations than health considerations.
Senator Collins. I believe that we do need to provide more
authority to the FDA, that we probably need to provide more
resources, but do we not also need to expect the FDA and the
Department of Agriculture to do a better job of targeting the
resources that they have now if we are going to truly protect
the American consumer?
Mr. Robertson. Yes. That is what a good part of the focus
of our work is, that you can make better use of your existing
resources and deploy them more effectively along the borders.
Senator Collins. Senator Durbin.
Senator Durbin. Thank you very much.
Thank you, Mr. Robertson. Let me just say the two charts
that you presented here with FSIS and FDA,\1\ I think, make the
case for the legislation I am pushing. It is time to put this
all under one roof, one set of rules, eliminate the bureaucracy
and the overlap, try to make certain that the American
consumers know that whatever the food product is, it is going
to be subject to a standard of inspection that is the best that
we can do at the moment, and I think you made that point in
your testimony.
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\1\ See Exhibits No. 4a. and 4b. that appear in the Appendix on
pages 130 and 131.
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But I want to walk through with you for a minute, so that I
can understand and the record is clear, the difference between
the FSIS, the Food Safety Inspection Service of the Department
of Agriculture, and the Food and Drug Administration. The Food
Safety Inspection Service, I think your report says, focuses,
maybe not exclusively, but primarily on meat and poultry
imports, is that correct?
Mr. Robertson. Correct.
Senator Durbin. And most of those meat and poultry imports
coming into the United States are probably frozen or processed,
is that correct?
Mr. Robertson. Senator, you get frozen, processed, and
fresh meat.
Senator Durbin. There is some fresh? Do you know what
percentage----
Mr. Robertson. Very little poultry.
Senator Durbin. Do you know what the percentage of fresh
would be?
Mr. Robertson. We could provide that for the record.
Senator Durbin. But in the FSIS or Department of
Agriculture approach to it, they really have three steps, as I
understand it. One step is to have a certificate from the
company that is exporting into the United States that they are
adhering to certain standards in terms of processing,
preparation, and inspection, step No. 1.
Mr. Robertson. Right.
Senator Durbin. Step No. 2 is that we actually send
employees from the Department of Agriculture out to take a look
at these plants overseas that are processing the meat and
poultry and make sure that the exporting companies are not
lying to us.
Step No. 3 is FSIS will take samples of food coming in to
find out whether it is safe. So there is a 3-step process here.
In contrast, the FDA just does the last step. As the food
presents itself at the border, we do an inspection.
Now, the suggestion here on equivalency is to give to the
FDA the same authority as FSIS. Let me walk through for a
moment, if I can. Your GAO report said that the FSIS in a given
year, and I think it was 1997, was able to visit 30 out of the
37 exporting countries to the United States. I am not sure what
that is, but let us say 80 percent. They visited 80 percent of
the countries which had plants processing meat and poultry and
are sending it to the United States with these certificates.
Now, do you know how many employees FSIS uses to meet their
responsibility?
Mr. Robertson. I think last year, they were about 84 staff
years.
Senator Durbin. Eighty-four staffers for all of the things
that I have mentioned, reviewing certificates, inspecting
overseas, and then doing the actual processing and inspecting
here in the United States?
Mr. Robertson. Yes.
Mr. Oleson. Senator, they use 12 staff years to do the
overseas work and the rest go to the port-of-entry inspection
operations.
Senator Durbin. OK. Now, the Food and Drug Administration
for its import food inspection employees, I believe, somewhere
in the neighborhood of----
Mr. Robertson. Total of 463 last year.
Senator Durbin. I thought I had read on page 25 of your
report the figure 257 staff years.
Mr. Robertson. It is 257 inspectors and there are 463
total. Those include laboratory analysts, that type of thing.
So it is 257 inspectors.
Senator Durbin. Contrasting the volume of imports between
FSIS responsibility and FDA responsibility suggests that FDA
has about 25 times the number of imports to deal with as the
Department of Agriculture, is that correct?
Mr. Robertson. Correct.
Senator Durbin. So that would lead us to conclude, what, in
terms of just looking at staff years? If they need 80 people in
FSIS to do 4 percent of the work that they would do in the Food
and Drug Administration, how many more employees would we need
in the Food and Drug Administration to do the same things that
the FSIS is doing today?
Mr. Robertson. I cannot give you an estimate on that right
now. But for the exact reasons that you have cited--because of
the huge volume of shipments that FDA is responsible for
assuring the safety of--it makes a lot of sense to me that,
rather than try to catch unsafe food with whatever number of
resources you have at the border, that you go back to the
countries to make sure that their systems----
Senator Durbin. I want to get to that next.
Mr. Robertson. Oh, OK.
Senator Durbin. I am just trying to stick with the basic
premise here, and if the premise is FSIS with 80 employees does
4 percent of the work that the Food and Drug Administration
should be doing, then it suggests to me we need 2,000 employees
in the Food and Drug Administration, assuming the FSIS is
efficient, to do the same thing that the Department of
Agriculture is doing with their responsibility. It is 25 times
the number of shipments, just roughly.
Mr. Robertson. OK, roughly.
Senator Durbin. Now, let me add another factor. You say we
have 400 and how many?
Mr. Robertson. Total of 463.
Senator Durbin. So we are talking about quadrupling the
number of inspectors in the Food and Drug Administration to
meet this responsibility that the FSIS has if we are doing
equivalency, 1-for-1. Maybe it will turn out we do not need
that many, but in the order of magnitude, that is a starting
point, quadrupling the number of inspectors in the Food and
Drug Administration.
Secondly, is there not a qualitative difference in your
inspection responsibility if you are going to a processing
plant for meat and poultry as opposed to going to the Nation of
Guatemala and looking at all of the fields where they plant
crops?
Mr. Robertson. I am not sure if I am following you, but the
purposes of the inspections would be totally different. In
going to Guatemala, what you would be doing if you were under
an equivalency system is looking at the system there. You would
be looking to see that it has the basic components that are
necessary to assure that, in essence, the food coming out of
there is at the same level of safety as what is coming out of
the United States. So you are looking at the big components of
the system. Do they have inspectors? Do they have a set of
laws? What do the laws say? Can they enforce the laws?
Senator Durbin. In the FSIS, they go a step beyond that, do
they not? They actually visit the plants.
Mr. Robertson. Yes. They do some plant sampling.
Senator Durbin. So when Dr. Camire comes before us and says
the origin of a lot of the contamination for fruit and
vegetables is very, very basic as to what very poor people who
are picking these vegetables are doing about their own hygiene
and the fields they work in----
Mr. Oleson. Senator, let me clarify one thing. When FSIS
goes over to a foreign country and visits a plant, they are
going to the processing or slaughter plant, not to the barns.
Senator Durbin. Understood.
Mr. Oleson. Also, they are going to basically verify that
the country's system is working. They are not going into that
plant to try to determine if it is sanitary and all that. They
are doing that, but it is to ensure that the system works, not
the individual----
Senator Durbin. But they are also looking at the sanitary
conditions.
Mr. Oleson. Yes, they are.
Senator Durbin. If they saw the system and all the papers
were in place and took a look at this plant and it was filthy--
--
Mr. Oleson. That is correct.
Senator Durbin [continuing]. They are going to do a visual
inspection. I am just trying to really compare, make sure we
have an accurate comparison between the responsibility of the
Department of Agriculture here and the responsibility we are
suggesting for the Food and Drug Administration. I am saying,
on the one hand, we are talking about a dramatic increase in
the number of employees in this agency if we are going to give
them equivalency and ask them to use the same standards.
Secondly, I think it is a little different challenge, a
discrete number of processing plants as opposed to a system of
agriculture in a foreign country. How many countries do we
import fruit and vegetables from?
Mr. Robertson. We are talking in the neighborhood of, what,
200 or so.
Mr. Oleson. I think there are 188 countries in the world.
FDA's records show something like 266 different countries since
they started their automated system--or 244, excuse me. That
number probably has some changes in names of countries and may
be counting some territories, but it is a lot of countries.
Senator Durbin. So let us say 200 as a rough figure, and
FSIS looks at 37 and they manage to visit 80 percent of them.
Now the Food and Drug Administration has the responsibility
under our suggestion here of looking at 200 countries and
trying to make sure they have enough people to visit them and,
at least, at a minimum, make sure that the standards they
purport to hold to are actually being followed.
Let me speak for a moment about the FDA process, and you
are going to have to update me here because I am going to tell
you what I saw a few years back and you tell me how it has
changed. I know it has changed in one respect.
When the shipment of tomatoes comes to the border, the FDA
inspector at Nogales, Arizona, would walk onto that loading
dock and would take a sample from different parts of the truck
and put it in a brown paper bag, mark it as to the shipper, and
send it off to the FDA lab. Is that about what you saw when you
visited, something like that?
Mr. Oleson. Yes, Senator. They do not use brown paper bags
anymore. They put them in ice packs generally to retain the
freshness and things of that nature. And then they fly them to
the lab instead of busing them.
Senator Durbin. They fly them to the lab. While they are in
the process, they punch into the computer the name of the
shipper and the grower that they are inspecting at that spot.
If nothing comes up to suggest that there has been a violation
in terms of what they have sent into the United States, the
shipment heads for the grocery store. The tomatoes are on their
way to Joel Domenic's in Chicago and Safeways all over the
United States while the sample is on its way to the laboratory.
In most instances, by the time they are finished in the
laboratory, reaching their conclusion, the product is already
on the shelf and may have already been sold.
Mr. Oleson. They have changed the speed in which they turn
their lab samples around now. They try to get them back in 24
hours. Under the conditional release which we are talking
about, the importer is responsible for retaining control of
that shipment until he gets a release from FDA.
Senator Durbin. But are all shippers under a conditional
release requirement?
Mr. Oleson. The way it works is that, basically, we do not
have bonded warehouses for FDA-type products, in a sense, so
they go to the importer's warehouse. Some of the importers
continue shipping products on if they are perishable to the
destination, but they are supposed to be able to bring the
products back if FDA finds they are violative.
Senator Durbin. And in 70 percent of the cases, they do not
get it back.
Mr. Oleson. That is part of our problem.
Senator Durbin. Now, let us assume that they find a
violation. It used to be that if they found a violation and the
shipment was already gone, the next time that particular grower
and shipper came through, they came up on the computer and then
a different standard was used. They were held until the
inspection was completed. Is that still the case?
Mr. Oleson. When they have a history of violations, they
put them on what they call automatic detention, or detained
without physical inspection is the correct term now. That means
that the importer still retains control of the shipment, but he
has to provide some evidence that that shipment is clean or
beats the U.S. standards. That is where they go and select a
private laboratory and the private laboratory pulls the samples
and does the test and provides the information to FDA.
Senator Collins. Senator Durbin, your time has expired from
this round, but we will do another round.
Senator Durbin. OK. Thank you.
Senator Collins. Mr. Robertson or Mr. Oleson, I want to
follow up on a point that Senator Durbin made. Even if we
quadrupled the number of FDA inspectors that we have, if FDA
continued to rely on port-of-entry inspections, if FDA
continued to allow importers to retain custody of suspect
shipments, if FDA still allowed the importer to select the
samples and the lab that was going to do the work, if FDA
continued to focus on shipments for reasons unrelated to health
risks, even if we increased the number of inspectors by a
factor of 4, do you believe that we would solve the problem and
that we would have a safer food supply coming into this
country?
Mr. Robertson. Well, again, that is why we are saying in
regard to FDA is the most effective use of any number of
resources that you wind up with is to make sure that the
countries that are exporting the products have systems, have
safety systems that are equivalent to ours. I do not care what
level of resources that you have. The idea is to develop a
system that basically tries to assure that the food is safe as
it is coming into the United States as opposed to trying to
catch it with inspectors once it reaches the border of the
United States.
Mr. Oleson. If I may add to that, Senator----
Senator Collins. Yes, Mr. Oleson?
Mr. Oleson. Port-of-entry inspections or end product
inspections have been widely discredited as being effective
means to ensure that something meets the standards it is
supposed to meet.
Senator Collins. That was going to be my very next
question. In your report, you used that phrase, that port-of-
entry inspections have been widely discredited. Could you give
us some history on that? Is it just GAO----
Mr. Robertson. No.
Senator Collins [continuing]. Or have other groups been
critical? Has not one of FDA's own advisory groups discredited
its system years ago?
Mr. Robertson. In fact, the United Nations Food and
Agriculture Organization has been critical of it and the
advisory group that you spoke of just a minute ago in 1991
basically called that approach an anachronism. So it not just
us that is saying, this is the way you should approach the
design of the inspection system.
Senator Collins. Mr. Oleson, do you want to add anything to
that, based on your work?
Mr. Oleson. I think he captured it fine there, Senator.
Senator Collins. I want to go back to the issue of focusing
the resources on shipments that are not related to health
reasons or health risks. It is my understanding, if I am
remembering your report correctly, that you found that in
fiscal year 1996, about 86 percent of the refused shipments by
the Department of Agriculture inspectors were not related to
health risks, is that correct?
Mr. Robertson. Yes, that is correct.
Senator Collins. Most American consumers would believe that
the inspection resources would be targeted towards health
risks, but you found that 86 percent of the Department of
Agriculture's refusal of shipments were not health related.
Mr. Robertson. Right.
Senator Collins. Is there a comparable figure for FDA?
Mr. Robertson. I do not think FDA has figures on the
refusal, is that correct?
Mr. Oleson. FDA has the information for the laboratory
tests they perform, which is actually about 0.6 of 1 percent of
all entries are actually sent to an FDA lab for testing. There
is about a 17 percent violation rate from those tests, but they
do not necessarily end up in a refusal. They could be appealed
or something may happen to allow them to continue entry. In
addition, the 1.3 percent, that is the difference between the
1.7 percent and the 0.6 percent, the 1.3 percent that are
physically inspected by an FDA inspector, they do not have the
refusal rate on that, so we do not know what their rejection
rate is.
Senator Collins. Is that not troubling, as well, that we do
not have the data?
Mr. Oleson. Yes, it is.
Senator Collins. GAO's review found another weakness that
we have not touched on yet and that is the system for
penalizing importers who do not obey the law. It is my
understanding that you took a look at the Customs Service's
operations in Miami and found--well, why do you not tell me
what you found when you looked at that. Mr. Oleson?
Mr. Oleson. For the Miami district, where we were able to
capture the information, Customs, in effect, for those improper
distributions of refused entries, they assessed penalties on
only 25 percent of those cases. And then when they actually
collected damages, it resulted in about 2 percent of what they
assessed.
An example would be, and this is one of the extremes, but
we have many of them, is for an incidence of swordfish which
was distributed. The initial assessment was for $100,000, but
the penalty that actually came out that was collected was $100.
We have another case of snow peas. The assessment was $16,000.
The collection was $200. They go on and on like that.
Senator Collins. So the assessment in the first case that
you gave us was actually $100,000 and the actual fine that was
paid was only $100?
Mr. Oleson. That is correct.
Senator Collins. Why is this happening? That does not
strike me as a very good deterrent if we are cutting fines and
penalties to that extent.
Mr. Robertson. We have already gone on record as saying
that there have been problems in the deterrent value of the
penalties in the past, and this is something, by the way, that,
as you know, we are going to be exploring further over the next
few months.
Senator Collins. Does this not encourage the unethical
importer to treat these fines as just a cost of doing business?
Mr. Robertson. Well, it would certainly say to him or her
that I am not going to be penalized very much if I go ahead and
do not carry out my responsibilities.
Senator Collins. I see that Senator Cochran and Senator
Brownback have joined us. We welcome you and I am going to,
instead of using the rest of my time now, turn to both of you
for questions, and then we will go back to Senator Durbin, and
then I may have a few concluding questions, as well. Senator
Cochran.
OPENING STATEMENT OF SENATOR COCHRAN
Senator Cochran. Thank you, Madam Chairman. I came to
congratulate you and the staff and the GAO for helping us
understand what is going on in this food inspection area. We
all have other responsibilities here in the Senate that
coincide with this situation. I know in my case, being on the
Agriculture Committee and also on the Appropriations Committee,
we have undertaken to conduct oversight reviews of these
programs, whether we are talking about the Food Safety and
Inspection Service at the Department of Agriculture or the Food
and Drug Administration's work under the obligations it has
under the law.
But what has come through to me during all of these
experiences is that we have a hard time getting all the facts
with just one hearing every year. For example, in the
Appropriations Committee, usually because of all the other
programs that we have to look at, and in the Agriculture
Committee, when we undertake a review from time to time, we
have limited resources. But Chairman Collins has undertaken to
mobilize the resources of this Subcommittee with the staff and
with GAO's assistance to really dig into this in a way that has
never been done before, and I think that is going to be very
revealing and helpful to us as we try to make decisions about
how much money to allocate to various inspection activities and
programs.
We have a sharing of responsibilities among agencies right
now, and sometimes it is confusing, who is responsible for
what. Things tend to fall through the cracks under the current
way things are organized, and I think your report points that
out. We need to have tighter controls of management over what
is being done, with follow-ups to be sure people pay their
fines, for example, which we just heard about, and there are
many other areas.
In seafood inspection, you mentioned the swordfish. We have
been trying to get seafood inspection laws reformed for a long
time now and we just never can quite get a consensus of support
here in Congress because of the various pressures from people
who are not for it for one reason or another.
But I think these hearings can serve a purpose there, too,
and that is to help convince other Members of Congress that we
need some reforms in these areas. We do not need just more
money pumped into the things that are being done in a slipshod
way, where they are and where there are shortcomings in the
system. We do not just need to add more fuel to that fire. We
need to put out the fire and we need to make some important
reforms and you are helping us to figure out how we can do that
and how we can do that in an effective way to help protect the
consuming public. I think we are going to be better off for
these hearings and I appreciate very much your conducting them
and leading us.
Senator Collins. Thank you very much, Senator. Senator
Brownback.
OPENING STATEMENT OF SENATOR BROWNBACK
Senator Brownback. Thank you very much, Madam Chairman, and
thank you for holding the hearing. I think this is a very
important topic and I appreciate you really leaning in and
looking and getting a focus on this. I appreciate the witnesses
and the report that has been done.
I come with some background on this topic and have had some
great concern about it. I was Agriculture Secretary in Kansas
for 6 years. I worked in the trade field, worked on the NAFTA
treaty with the U.S. Trade Representative's Office. One of the
things that was always raised to us was that as you expand your
agricultural trade, as you lower those barriers, particularly
as you lower what was always called the non-tariff barriers,
the sanitary, phytosanitary issues, that is good for our
exporters but there is always a reciprocity that goes with it,
which is that then they can import into this country and a
number of our producers are always questioning the production
systems that were used in other nations to produce these
products and were they under the same EPA regulations,
inspection regimes as what ours are.
I missed a good portion of this hearing, but did you find
substantial differences in inspection regimes in these
countries coming into ours?
Mr. Robertson. The scope of our work this past time around
did not include looking at other countries' inspection systems.
Senator Brownback. Would you advise us to go further and
look at that, as well?
Mr. Robertson. Well, one of our recommendations, basically,
is that from an FDA perspective, that FDA be given authority to
require that countries that are exporting food to us have
systems that are equivalent to ours, food safety systems that
are equivalent to ours.
Senator Brownback. That is already required under a lot of
the trade negotiated treaties, so if it is not in place, we
already have footing to pursue something of that nature. I
think we have to keep much more on top of this. It has been a
legitimate issue raised for some period of time and we need to
do something about that.
One thing I would like to ask you about, in your report,
you state that there is up to 9,100 deaths occurring each year
because of foodborne illnesses.
Mr. Robertson. That is estimated, yes.
Senator Brownback. Estimated? That seems extraordinarily
high. Could you explain the methodology you used to obtain that
number?
Mr. Robertson. Basically, it is not our methodology. That
comes out of some work we did a couple of years ago, and
basically, in that work, what we did is reviewed a number of
studies that tried to get a handle on the impact of foodborne
illnesses. What that study did is basically identified the
research that had been done and presented the research in our
report. So that 9,100 figure was from some of the research that
we uncovered doing work for that report. It was not our
estimate.
Senator Brownback. So that is for all food-associated
foodborne illnesses----
Mr. Robertson. Right.
Senator Brownback [continuing]. Whether they come from
imported products--I mean, you cannot really comment on the
methodology of that?
Mr. Robertson. No. We do talk about where the figures came
from in that report. We will just leave a copy of the report
with you.
Senator Brownback. OK. I appreciate that, and Madam
Chairman, I appreciate your hearings. I do think we owe it,
obviously, to the consumers to have a safe food supply. I think
we also owe it to producers that they be competing against
equivalent-based systems in other countries and that we need to
look at that aggressively, as well. While this study did not
cover that area, they are supposed to be equivalent-based
systems.
It is supposed to be on environmental and on food safety
inspection systems and I hope we can pursue and push that, that
as we push these fines being implemented at the level that they
are supposed to be, we also push the inspection system to go
in-country to make sure that these nations that are producing
products for our people are doing it under the same basis that
our producers have to go under, and thanks for holding the
hearing.
Senator Collins. Thank you, Senator. Both you and Senator
Cochran have a great deal of expertise in the agricultural
field and I know that your participation is going to be really
helpful to us as we go forward in this area. Senator Durbin.
Senator Durbin. Thanks, Madam Chairman. I have one last
area of questioning. I will try to make it as brief as I can,
and it is about the laboratory involvement here, which is an
important part of your conclusion.
If I remember correctly, under the FDA inspection standard,
once a shipment came in, a sample was taken and sent to the FDA
lab. If the results came back and indicated that there was
something wrong with that shipment, the companies were then put
on notice that the next shipment that came in would be under
surveillance, which meant that such shipment had to be held
until another sample could be tested at an FDA lab. It could
not be sent into commerce. And finally, if there was a second
violation, the shipment would be detained, and detained until
the shipper/grower had submitted evidence that a test had been
taken on that shipment and that it had no problem.
So there was an increasing magnitude of inspection and
detention based on whether we had bad actors and violators. Is
that still basically the regime that is followed?
Mr. Oleson. I believe so, Senator. I am not sure about the
second surveillance test, if that is still required there,
where they notify them that they will be on surveillance. We
would have to check that.
Senator Durbin. OK. Now, your observations about
laboratories, I think, relate to detentions only. Assuming
private laboratories are chosen by growers and shippers because
they have got a history of problems, and someone in that
laboratory or someone associated with the shipper picks the
sample off the truck, your concern, and obviously a legitimate
concern, is that it is a little too cozy there.
Mr. Robertson. Yes, sir.
Senator Durbin. There is no independent third party
involved in this process.
Mr. Robertson. Correct.
Senator Durbin. OK. Is there any other evidence of private
laboratories being brought into this system, other than that
case of detention by the FDA where they have got a bad actor?
Mr. Robertson. Actually, I think FDA is moving towards
using them in other areas, too. Can you elaborate on that a
little bit?
Mr. Oleson. Yes, Senator. They are moving toward using
private laboratories for their normal processes. Seafood is the
most recent example they are trying to move toward, recognizing
their own labs are getting overburdened, so they are trying to
shift some of the work back to private ones.
Senator Durbin. When I visited FDA's inspection laboratory
for seafood in the Boston area, it was a very limited
operation. You would be surprised. The one thing that I recall
about that particular visit is that many times, seafood will
tell you when it is bad. [Laughter.]
Mr. Oleson. That is one of the tests they use.
Senator Durbin. The inspector told me to take a whiff of
one of those which he called a neck-snapper, not a red snapper
but a neck-snapper, and once I took a whiff, I understood what
he said. But that is clearly an area, poultry and fish are
areas of real serious concern in terms of foodborne illnesses.
Madam Chairman, thank you very much.
Senator Collins. Thank you very much, Senator Durbin.
Mr. Robertson, I only have a few more questions, but I do
want to point out an issue that troubles me, and that is that
these problems in our system for food safety have been
exacerbated by the increase in imports, but they have existed
for a very long time. I looked back at a December 1977 report
by the Governmental Affairs Committee. It is over 20 years ago
and it was part of a 6-volume series on various aspects of
Federal regulation.
One volume was on our food safety system, and the Committee
concluded in part that, ``Divided responsibility between the
Department of Agriculture and the Federal Food and Drug
Administration for food regulation has created a regulatory
program which is often duplicative, sometimes contradictory,
undeniably costly, and unduly complex.'' Have we made any
progress in 21 years?
Mr. Robertson. Well, I am sorry to say, but the situation
really has not changed a whole lot, and I am sorry that Senator
Durbin is not here because earlier he did just a fantastic job
in describing the problems with the current piecemeal approach
that we are taking to food safety.
Senator Collins. I will play his role right now. I have two
cans of soup. One is a vegetable soup, one is a vegetable beef
soup. They are produced in the same factory. Can you tell me
who inspects the vegetable soup, Mr. Oleson, and who is
responsible for inspecting the vegetable beef soup?
Mr. Oleson. Let us start with the vegetable beef soup. It
seems it has beef in it, and under the rules, that comes under
FSIS's regulatory authority. FSIS will inspect that plant every
day each and every operating shift. So if they operate two
shifts and an overtime, they will be in there three times in
the same day. For that plant, depending on the size of those
plants, they have permanent inspectors in those plants.
To take the other one, the vegetable soup, since there is
no meat or poultry in that, that is under FDA's regulatory
authority and they will, then, inspect that plant--they do not
have a mandatory inspection requirement, but they will visit
that plant maybe once a year or something like that.
Senator Collins. Are we misallocating our resources?
Mr. Oleson. Absolutely.
Senator Brownback. I think it just tells you to eat more
beef. [Laughter.]
Senator Collins. Spoken like a Senator from Kansas.
Senator Brownback. It is good for you.
Mr. Oleson. To add one more part to that, the real problem
with that is not so much what is the food that is in it, it is
the processing that they undergo, and low-acid canned foods are
a high-risk processing operation and we want to ensure it is
done right because of botulism. So it is the process that makes
a difference in that case.
Senator Collins. The other area that you hit upon in your
report that we have talked about at length today is the issue
of giving FDA what is known as equivalency authority, which the
Department of Agriculture already has. This means that FDA
would essentially certify the food safety system of a country
before we would get imported foods from it, is that correct,
essentially?
Mr. Robertson. That is essentially correct.
Senator Collins. Now, the President has proposed
equivalency authority for the FDA, but we seem to be getting
conflicting signals about whether the FDA wants to have this
authority. Could you explain to the Committee the reaction that
you got in your discussions with FDA on the issue of mandatory
versus discretionary, concerns about impact on trade?
Mr. Robertson. Sure. FDA, in responding to our
recommendation that basically would require equivalency for
other countries' food safety systems, basically said that you
cannot do that in a mandatory fashion because it is going to
disrupt trade. We think that it should be done on a
discretionary basis.
Senator Collins. We, meaning FDA?
Mr. Robertson. Exactly. Our response to that is that we are
not talking about banning all imports until a country has a
system equivalent to ours. What we are talking about is phasing
in this equivalency requirement over what could be a relatively
long period of time. But our point still is, again, I keep
going back to the statistics that say there are 2.7 million
entries arriving at U.S. ports each year and you cannot hope to
assure the safety of those entries with just port-of-entry
inspections. You have got to go back to the source. You have
got to go back to the other countries to make sure that their
systems are equivalent to ours.
Senator Collins. So if we do not change the system and we
continue to have this flood of imports, do you believe that we
are going to be posing an ever-greater risk to the American
consumer?
Mr. Robertson. Yes. I think the system needs to be
strengthened and we have presented a couple of ways that it can
be strengthened so that those risks are decreased.
Senator Collins. Thank you very much. We very much
appreciate your assistance in this area.
I would now like to call our final witness for the day. His
name is Reggie Jang. Mr. Jang is awaiting sentencing after
pleading guilty in California on Federal charges of accepting
bribes from a company seeking to bypass inspections of imported
food products. He is currently cooperating with Federal law
enforcement officials against other individuals indicted in
California.
Pursuant to the Subcommittee's agreement with law
enforcement officials which has led to the testimony we are
going to hear today, Mr. Jang will testify only about his
knowledge of the FDA's import inspection system and will not
provide any specific testimony about current Federal criminal
investigations in which he is a witness or a defendant.
Mr. Jang retired in August of 1997 after serving almost 36
years as a consumer safety inspector at the Federal Food and
Drug Administration and he will testify today about his
firsthand experiences with regard to the food import inspection
system.
Mr. Jang, I would ask that you now stand and raise your
right hand. As I have explained to the other witnesses, all
witnesses are required to be sworn in.
Do you swear that the testimony you are about to give to
the Subcommittee will be the truth, the whole truth, and
nothing but the truth, so help you, God?
Mr. Jang. Yes.
Senator Collins. Thank you. Please proceed.
TESTIMONY OF REGGIE JANG, FORMER FOOD AND DRUG ADMINISTRATION
CONSUMER SAFETY INSPECTOR
Mr. Jang. Madam Chairman and Members of the Subcommittee,
thank you for allowing me to testify today with regard to the
adequacy of the Nation's food import inspection program.
As you mentioned, I retired in August 1997, after serving
almost 36 years as a consumer safety inspector at the Food and
Drug Administration. As you stated, Madam Chairman, I recently
pleaded guilty to a felony in Federal court in San Francisco in
an ongoing investigation and I am scheduled to be sentenced
this fall. Consistent with the Subcommittee's subpoena, I
cannot discuss any details of the ongoing investigation or my
case.
Today, I would like to focus my remarks on some of the
weaknesses in the current food import system. I do so not out
of any sense of resentment or revenge but out of my concern for
our Nation's food supply. I also testify out of my respect and
concern for the FDA, as well as my desire to atone for any past
misdeeds.
Port-of-entry inspections are ineffective. Port-of-entry
inspections are ineffective because many importers or brokers
acting on the behalf of importers participate in port shopping
and clear shipments through ports of entry where FDA inspectors
release specific types of food products without examination.
For example, some unscrupulous food importers bring food
products from Southeast Asia through ports of entry where FDA
inspectors rarely see such products and are unfamiliar or
unaware that these products are on the automatic detention or
alert list.
Unscrupulous importers also have a tendency to port shop
and use, in some cases, two to four different aliases to hide
their identity. All these importers have to do is to use the
Social Security number and the name of a relative to import as
another company.
Importers know through word of mouth and by sharing of
information with other importers which ports of entry are
easier to bring in their food products. It is not unusual for
West Coast importers to clear their shipments on the East Coast
and send by rail the products across the country, while still
making a reasonable profit. On the West Coast, importers have
brought food products in at the Port of Los Angeles and
transported the products up the coast to San Francisco for a
cost of only $300. This small cost makes it very tempting to
port shop.
The FDA's newly implemented paperless system, referred to
as the OASIS system, also makes it easier to bring in unsafe
foods. Importers know that if a shipment contains products with
a history of no problems or violations, the FDA will release
the item electronically with no questions asked.
One technique used by unscrupulous importers is to stack
questionable food products in the back of a container and place
the good products in the front. It is very likely that an FDA
inspector would release this entire shipment with no questions
asked. Another technique is to commingle questionable food
products in a container with other types of merchandise, such
as furniture.
Based on my experience, I believe it would be very
beneficial for the FDA to target more inspections of importers'
warehouses and perform more surveillance of retail outlets to
determine the sources of the questionable food products they
have in storage and on their shelves.
We know there is and will continue to be a shortage of
consumer safety inspectors. Therefore, it is important that the
FDA, in coordination with other Federal enforcement agencies,
continues to make effective use of blitzes. Blitzes are short-
term, very intensive surveillance efforts of a specific food
product or a specific port of entry. Let me emphasize that
blitzes are effective only if all FDA districts do them, or
else it will invite port shopping.
The FDA is not deploying its inspectors effectively. Each
FDA district office has its own ideas on how to best utilize
its inspectors for collecting samples and conducting
examinations of imported food products. Sometimes management is
inflexible to new ideas, even though the ideas may be common
sense. For example, some inspectors have to spend more than
half their productive time traveling to and from locations to
collect samples or conduct examinations of imported foods. It
may take 30 minutes to collect a sample, but it may take from 2
to 3 hours of travel time.
One possible solution would be to place FDA inspectors
closer to the proximity of their workload. FDA inspectors could
share office space with a Customs office which is already
located at the port of entry. FDA import operations are all
computerized and assignments could be transmitted
electronically from the district office to the inspector.
Proper deployment of inspection resources may not be the
only problem. The techniques on how to examine suspect food
products must be updated. The cheaters are now smarter and more
innovative in hiding questionable products from the FDA. The
demand and the potential revenue of up to four times the
original purchase price makes more importers willing to take
the risk. Penalties and fines now set at three times the
invoice value should be increased to three times the expected
selling price.
Annual work plans are inadequate. For FDA district offices
to fulfill their annual work plan is often very difficult. The
number of samples to be collected, as required in the work
plan, are non-achievable because the plans often are not based
on current or accurate data and field offices are not allowed
to provide input.
The district offices try to accomplish what is dictated by
FDA headquarters, but the requirements are often too high. The
FDA district does not take into account port shopping,
importers moving to other geographic areas, importers going out
of business, demand decline of selected products, importers
shipping directly to buyers, the availability of inspectors to
collect samples, and the capability of the laboratory to handle
samples.
Regional and district management place tremendous pressure
on food import inspectors to accomplish the unrealistic goals
in the work plan. There always has been a concern by management
of losing staffing in the districts and regions if the workplan
numbers are not met. Inspectors try their best to collect the
samples and conduct the examinations, but the trade-off is
strictly one-sided. There is insufficient coverage given to the
areas of greater risk, such as suspect importers or food
product that may contain potential health risks.
With regard to health risks, FDA inspectors are not
provided sufficient and timely information on known health
risks associated with imported food. It would be a tremendous
benefit to inspectors when they are at an importer's warehouse
to know that certain products have been discovered to pose a
greater health risk than others, or possibly that recent
laboratory results have shown a particular product to be
contaminated.
The import operations branch is the focal point of alerting
all field offices to any health risk problem. An alert notice
should be issued by them. In most cases, when an inspection by
a field office discovers a problem food product, that
information is generally circulated only to the other
inspectors in the district and often not circulated nationally.
Current import procedures allow fraud and abuse. It is very
easy for an importer to substitute food products from a good
shipment to a rejected one. Most FDA field offices allow
movement of imported food shipments to the importer's own
warehouse before sampling. If the FDA rejects a shipment, that
shipment will remain at the importer's warehouse for either
private laboratory sampling, FDA audit sampling, or re-
exportation, but that food is still in the importer's control.
Importers have been known to sell portions of a rejected
food shipment and replace the products sold with products they
have scheduled to arrive in another shipment. When an
unscrupulous importer has a shipment rejected by the FDA and
must re-export it out of the United States, the importer
substitutes food from a good shipment to increase the chances
it will pass inspection when the importer tries to re-enter
that shipment.
In addition, when a private laboratory selects a food
sample for analysis, there is no assurance that the importer
shows the analyst the rejected product. The unscrupulous
importer may show the lab analyst a good product stored next to
the rejected product.
The FDA should have procedures to monitor and track
importers who substitute food products. After one substitution
violation, future rejected shipments should be placed in a
bonded warehouse controlled by the Customs Service at the
importer's expense.
Some importers also ignore FDA's recall of food products
for destruction or re-export and distribute the products to
American consumers. The reason is very simple--money. Importers
can ignore the FDA's recall notices, pay the fine, and still
make a reasonable profit.
That concludes my testimony, and I will try to answer any
questions that you may have. Thank you.
Senator Collins. Thank you, Mr. Jang.
Mr. Jang, you discussed in your testimony that some
importers use port shopping in order to ship questionable food
products into the U.S. economy. Based on your experience, how
common is port shopping? Is this a widespread problem or is it
just an isolated example that you told us about?
Mr. Jang. Port shopping is getting to be a widespread
problem, a wide area problem. Personally, I know of at least
several ports of entry that they are port shopping, bringing in
rejected products back into the country. The communication of
importers who port shop is very good from importer to importer.
They know which port of entry is easier to bring in their
product without sampling, especially their problem products.
Senator Collins. So an unscrupulous importer who has a
questionable product knows which ports are easier to ship the
product into than others? Some have tougher inspections than
others?
Mr. Jang. Yes.
Senator Collins. So this can have a real impact on our food
safety, is that correct?
Mr. Jang. Yes.
Senator Collins. The General Accounting Office discussed
Operation Bad Apple, where government investigators found that
in 70 percent of a particular case, the unsafe products were
released into the American marketplace. The investigators found
that importers often used product substitution. For example,
they substituted a good product for the laboratory tests that
the FDA required for the tainted product. Can you explain to us
how importers can get away with that, how they could substitute
good products for bad?
Mr. Jang. In past years, cartons that came in, say, about
10 years ago were specifically marked and identified to a
specific invoice and packing list. You can specifically
identify that shipment with those paper documents. It would
have on the carton itself the location of the importer, the
carton number, like you have canned pineapple number 1 to 100,
canned mushrooms 101 to 200. Some would have the production
code and the name of the vessel.
Now, because Customs has relaxed their labeling
requirements, the labeling on cartons is now identical from
shipment to shipment. You cannot specifically identify one
shipment from another shipment.
Senator Collins. So the shipping label is not going to
prevent product substitution, the substituting of good products
for bad, is that what you are telling us?
Mr. Jang. Yes.
Senator Collins. I have one final question for you before I
turn it over to Senator Durbin. What has been your experience
in using the current system of fines and penalties to deter the
illegal distribution of imported foods?
Mr. Jang. This is a slap on the wrist. There is no
deterrent to prevent importers from selling rejected
merchandise. The fines are mitigated downward. It is, like you
mentioned, it is a cost of doing business.
Senator Collins. Thank you, Mr. Jang. Senator Durbin.
Senator Durbin. Thank you, Madam Chairman.
Mr. Jang, I am interested in the personal contact which an
FDA inspector has with a party interested in a shipment that is
being inspected. What is the usual contact? Is there a person
there with the shipment when the FDA inspector does the actual
inspection?
Mr. Jang. Generally, when an inspector goes to an
importer's warehouse to examine the shipment, there will be
someone there to show the inspector the shipment or where it is
located. It could be the importer himself or it could be a
laborer to point out where the shipment is located.
Sometimes, the importer would stack the shipment in such a
way in the warehouse that it would be difficult for the FDA
inspector to reach or sample the product. You might stack it
four stacks high and then the FDA inspector would be unable to
obtain the sample. So the importer at that time might offer to
assist the FDA inspector by going through it and collecting a
sample. That is where product substitution might take place.
Senator Durbin. Now, you talked a lot about fraud and abuse
in the current system, and what I am trying to establish is
your experience. Is this fraud and abuse well known within the
FDA to be associated with specific importers?
Mr. Jang. It essentially is a problem that we have
identified, that we have caught, or that Customs have caught,
that have substituted.
Senator Durbin. What I am trying to establish is whether or
not the people working within the FDA, in your experience,
would say, listen, when you go over to that importer's
warehouse, be careful because we know in the past they have
been guilty of practices which raised many questions. Is that
the case?
Mr. Jang. Yes. We have a listing of problem importers. When
we do issue assignment, we would forewarn the inspectors that
this is a problem importer. Mostly, in the case of a problem
importer, we would do an intensive type of examination along
with U.S. Customs in a Customs-controlled warehouse where we
have it there so there will be no manipulation by the importer.
Senator Durbin. Because there is always a danger of
manipulation.
Mr. Jang. Right.
Senator Durbin. The importer's employee may not want you to
see the shipment, may stack it too high or keep some part that
is objectionable way from you. That is the problem that you
might run into.
Mr. Jang. Yes, or substitution.
Senator Durbin. Can you associate these importers with any
specific countries of origin? Is there any country of origin
for the shipment that is a perennial problem in terms of the
shipments coming into the United States and the importers
trying to circumvent the law?
Mr. Jang. On the West Coast, we deal mostly with Southeast
Asia or Asian countries. There, we find a high degree of
problem with many of the shipments.
Senator Durbin. From any particular countries?
Mr. Jang. I would say in most of the countries, not any
particular country. We do find a high rate from China, from
Thailand, from the Philippines, and from Hong Kong.
Senator Durbin. As I understand it, the GAO report says
that the Food and Drug Administration does not have the
authority to fine importers who distribute adulterated food
shipments or fail to retain shipments for inspection. The Food
and Drug Administration relies on a bond agreement between
Customs and the importer for those shipments valued at more
than $1,250 as a way to achieve compliance.
I assume that goes back to your point, that these importers
know that they have very little to lose by trying to cheat when
it comes to inspection.
Mr. Jang. Yes. Even though the importer paid a fine for not
retaining the shipment for FDA inspection or a rejected
shipment is disposed of before they are supposed to re-export
it or destroy it, they still make a reasonable profit from
that. You can make from two to four times the original invoice
value of the merchandise.
Senator Durbin. Your recommendation about tripling the fine
based on the value of goods rather than the invoice price is
one that GAO also follows, and I think, Madam Chairman, it is
one thing that we ought to seriously consider as part of these
hearings, that we give additional authority to the Food and
Drug Administration so that those who try to defy the system
really have a penalty that might catch their attention.
Mr. Jang, thank you for your testimony.
Mr. Jang. You are welcome.
Senator Collins. Thank you very much, Senator Durbin.
That concludes our hearing for today. As I mentioned in my
opening statement, this hearing is the first in a series of
four hearings that the Subcommittee will be holding to examine
the issue of the safety of our Nation's food import system. We
will be announcing a schedule for those hearings shortly.
The second hearing will focus on a case study involving
tainted raspberries that were imported from Guatemala. We will
trace how those raspberries got through the current system.
The third hearing will look at fraud and abuse in the
system, an issue that Senator Durbin and I have discussed this
morning.
The final hearing will focus on the remedies to this
problem. We will hear from all the Federal agencies that are
involved and we will discuss proposals for reform that have
been put forth not only by the GAO but by Senator Durbin,
Senator Coverdell, Senator Brownback, Senator Mikulski, and
Senator Cochran and others who are interested in this area. We
hope that these hearings will lay a foundation for real reforms
that will help ensure that the safety of our imported foods do
not compromise the health of the American public.
I want to thank Senator Durbin for his participation today
and I want to thank the staff for its hard work. I particularly
want to thank Dr. Stephanie Smith of my staff. She is a food
scientist who is on loan to us who has brought a whole new
degree of expertise to the Subcommittee's deliberations.
Finally, let me say that our plan had been to donate to a
food kitchen the fruit that we bought, but based on what I have
learned today, I am going to ask the staff to consult very
closely with Dr. Camire before we do that, to make sure that we
are not sending unsafe food to an unsuspecting food kitchen.
Thank you very much. The hearing is adjourned.
[Whereupon, at 12:05 p.m., the Subcommittee was adjourned.]
A P P E N D I X
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